NIDCR Clinical Research Protocols

NIDCR conducts clinical studies on the NIH campus in Bethesda, Maryland. Currently, NIDCR-supported clinical trials are open or will soon be open for patient recruitment at the NIH Clinical Center. Below is a list of all clinical research protocols, including studies that are not open for recruitment.

NIDCR clinical research protocol

1. 16-D-0040 Janice Lee, DDS, MD, MS-Natural History of Craniofacial Anomalies and Developmental Growth Variants

This is a natural history study that will examine craniofacial anomalies that affect the normal development of the facial skeleton, including birth defects and dentofacial developmental abnormalities that express themselves with the growth of the individual. Craniofacial anomalies may be rare and present at birth, such as hemifacial microsomia (1 in every 7500 live births), or common, such as dentofacial deformities including the “Habsburg Jaw” or mandibular prognathism (1% of the US population) that becomes apparent as a child enters puberty. These are striking disorders as they involve the face and surrounding structures, which is a focal point of self-identity and are intimately tied to quality of life and daily function. The primary objectives of this study are: To characterize rare and common craniofacial anomalies using both extensive clinical evaluations, 3D cone-beam computed tomography-based geometric morphometric and cephalometric analyses, and surface morphology, and to determine the genetic variants for rare and common craniofacial anomalies. The secondary objective is to establish a curated craniofacial phenomic/genomic database. The study population includes individuals ages >2 years with any craniofacial anomaly but will focus on two specific conditions that affect facial skeletal development: hemifacial microsomia and mandibular prognathism in children and adults. Up to 1920 subjects and family members as well as 480 healthy volunteers will be recruited through referrals from NIH or outside providers and institutions. This natural history protocol will generate research data that will improve the understanding and etiology of craniofacial dysmorphologies.

2. 15-D-0051 Ilias Alevizos, DMD-A Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjögren’s Syndrome Characterization of Diseases with Salivary Gland Involvement

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the clinical and biologic efficacy, as well as the safety of multiple SC doses of AMG 557/MEDI5872 in adult subjects with pSS. The study will be conducted at approximately 15 sites in Europe and North America. A total of 42 subjects will be randomized in a 1:1 ratio to receive a fixed SC dose of 210 mg AMG 557/MEDI5872 (n = 21) or placebo (n = 21) every week (QW) for 3 weeks (Days 1 to 15) and then every 2 weeks (Q2W) for 9 weeks (Days 29 to 85). Beginning on Day 99, all subjects (n = 42) will receive a fixed SC dose of 210 mg AMG 557/MEDI5872 QW (Days 99 to 113) and Q2W (Days 127 to 183) for an additional 12 weeks. On Day 106, subjects who had received placebo will receive a blinded dose of AMG 557/MEDI5872, and subjects who received AMG 557/MEDI5872 will receive a blinded dose of placebo (as these subjects would have already achieved steady-state levels of AMG 557/MEDI5872). The primary hypothesis is that subjects with primary Sjögren’s syndrome (pSS) treated with AMG 557/MEDI5872 will have improvement in objective measures of disease activity. The secondary hypotheses are that AMG 557/MEDI5872 will lead to a decrease in biomarkers (peripheral blood and minor salivary gland tissue), reflecting the activity of the inducible T-cell costimulator (ICOS):B7-related protein-1 (B7RP-1) pathway in subjects with pSS; that AMG 557/MEDI5872 will have an acceptable safety profile in subjects with pSS; and that subjects with pSS treated with AMG 557/MEDI5872 will have improvement in subjective measures of disease activity. The study population is representative of the subset of pSS subjects who have more systemic inflammation and, in general, would be considered for treatment with biologic therapies. Existing data from the literature strongly suggest that this is also the subset of subjects where abnormalities related to B7RP-1-ICOS activation are more pronounced. Based on the gender distribution of pSS, it is anticipated that a predominantly (> 80%) female population will be recruited. Vulnerable populations will not be included in this study.

3. 15-D-0097 Ilias Alevizos, DMD-Characterization of Diseases with Salivary Gland Involvement

Dental caries and periodontal disease are closely associated with the oral biofilm known as dental plaque. Much is known about the makeup of this biofilm, especially at its early stage of development (i.e. up to 12 hrs following tooth cleaning). The primary initial colonizers are streptococci, and actinomyces (Nyvad B and Kilian M 1987; Diaz P I et al 2006). These bacteria coaggregate frequently with one another by a mechanism that involves binding of protein adhesins on the surface of one cell to complementary cell-surface receptor polysaccharides (RPS) on streptococci (Cisar J O et al 1997). Coaggregation profiles are known for a wide range of oral actinomyces and streptococci. However, despite the potential significance of these interactions in biofilm formation, little is known about their occurrence within oral biofilms in situ. The objective of this study is to determine and compare the influence of coaggregation on the spatial organization of bacteria in supragingival dental plaque formed under conditions of normal salivary flow (Arm 1 of the protocol) or increased salivary flow (Arm 2 of the protocol).

4. 15-D-0129 Jay Chiorini, PhD-Open-label, dose-escalation study evaluating the safety of a single administration of an adeno-associated virus vector encoding human aquaporin-1 to one parotid salivary gland in individuals with irradiation-induced parotid salivary hypofunction

The treatment of most head and neck cancer patients includes ionizing radiation (IR). Salivary glands in the IR field suffer irreversible damage; this damage impacts patients’ quality of life. There is no conventional treatment available to correct this condition. Our research group has been developing an adeno-associated virus (AAV) vector based on the hypothesis that this vector is capable of safely transferring the human aquaporin-1 (hAQP1) complementary deoxyribonucleic acid (cDNA) gene to parotid glands of adult patients with IR-induced salivary hypofunction, resulting in an elevated salivary output. Human AQP1, the archetypal water channel, is a plasma membrane protein that facilitates water movement across lipid bilayers. Minipig studies have shown that the AAV2hAQP1 strategy for restoring salivary flow to IR-damaged salivary glands is effective without untoward effects after salivary gland delivery. As a proof of concept that AQP1 would restore saliva flow in a human population, we recently completed a phase 1 clinical trial (06 D 0206) using an Adenovirus-based vector encoding AQP1 to a single previously irradiated parotid gland in eleven patients using an open label, single dose, dose-escalation design (Baum et al. 2012). All patients tolerated vector delivery and study procedures well and positive objective and subjective responses were seen in five patients, all at doses <5.8x109 vector particles (vp)/gland. At higher doses the patients possibly initiated an immune response to the vector and no improvement in gland function was observed. These findings have encouraged us to pursue studies with AAV2 based vectors, which have demonstrated lower immunogenicity and more stable expression compared with adenoviral vectors. The purpose of this clinical protocol is to test the safety of AAV2hAQP1, with some measures of efficacy, in adult patients with established IR-induced parotid gland hypofunction. The targeted tissue site for the AAV2hAQP1 vector in the proposed study is a single parotid gland. In this Phase 1 dose-escalation study, safety will be evaluated using conventional clinical and immunological parameters. The primary outcome measure for biological efficacy will be parotid gland salivary output, Dental caries and periodontal disease are closely associated with the oral biofilm known as dental plaque.

5. 14-D-0145 Michael Collins, MD -Open-label Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Intravenous NPSP795 in Autosomal Dominant Hypocalcemia Due to Mutations in the Calcium-sensing Receptor Gene: A Drug Repurposing Study

This is a non-randomized, open-label study in subjects with ADH. Subjects will first undergo an outpatient screening visit to assess eligibility and optimize medications. Subjects who are managed with high-dose cholecalciferol/ergocalciferol (e.g., 50,000 to 100,000 units daily) will be transitioned to calcitriol and must have a 25-hydroxy-vitamin D level within the normal range prior to advancing to the treatment phase of the study. Within 3 months following the screening visit, eligible subjects will be admitted to the National Institutes of Health (NIH) Clinical Center (Day -1) and will remain there for up to 6 days. Subjects who are treated with calcitriol will be asked to discontinue this medication 2 days prior to the start of the NPSP795 infusion on Day 1. Subjects will be off of the calcitriol for 1 day as an outpatient and will be observed in an inpatient hospital setting starting on the second day following calcitriol discontinuation. The Primary Objectives are: to evaluate the safety and tolerability of an intravenous (IV) infusion of NPSP795, a calcium receptor antagonist (calcilytic), in subjects with autosomal dominant hypocalcemia (ADH) resulting from activating mutations in the calcium-sensing receptor gene (CaSR), evaluate the ability of various doses of NPSP795 to stimulate parathyroid hormone (PTH) secretion, increase blood calcium, and decrease renal calcium excretion in this population. The Secondary Objective is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of NPSP795

6. 13-D-0014 Niki Moutsopoulos, DDS, PhD-Bacterial Arrangement in Supragingival Biofilms

Dental caries and periodontal disease are closely associated with the oral biofilm known as dental plaque. Much is known about the makeup of this biofilm, especially at its early stage of development (i.e. up to 12 hrs following tooth cleaning). The primary initial colonizers are streptococci, and actinomyces (Nyvad B and Kilian M 1987; Diaz P I et al 2006). These bacteria coaggregate frequently with one another by a mechanism that involves binding of protein adhesins on the surface of one cell to complementary cell-surface receptor polysaccharides (RPS) on streptococci (Cisar J O et al 1997). Coaggregation profiles are known for a wide range of oral actinomyces and streptococci. However, despite the potential significance of these interactions in biofilm formation, little is known about their occurrence within oral biofilms in situ. The objective of this study is to determine and compare the influence of coaggregation on the spatial organization of bacteria in supragingival dental plaque formed under conditions of normal salivary flow (Arm 1 of the protocol) or increased salivary flow (Arm 2 of the protocol).

7. 13-D-0025 Rachel Gafni, MD-Open-label Dose-titration Study of the Tolerability and Efficacy of Cinacalcet to Treat Fibroblast Growth Factor 23 (FGF23)-mediated Hypophosphatemia

The primary objective of this protocol is to evaluate the tolerability of cinacalcet in individuals with fibroblast growth factor 23 (FGF23)-mediated hypophosphatemia, using an open-label, dose-titration study of once-daily dosing. Secondary objectives are to evaluate the pharmacodynamics of cinacalcet in this subject population and to explore the efficacy of cinacalcet by comparing a) level of oral phosphate required at baseline to the level required at maximum tolerated dose (MTD) and b) change in renal phosphate handling from baseline to MTD. Tertiary objectives are to evaluate tolerability, pharmacodynamics, and efficacy of twice‑daily dosing of each subject’s MTD of cinacalcet after completion of the once-daily dose-titration phase. A final objective is to determine the length of time it takes for subjects to return to their pre-treatment steady state once treatment is complete. Up to 17 subjects with FGF23-mediated hypophosphatemia will be treated.

8. 13-D-0033 Janice Lee, DDS, MD, MS-Diagnosis and Treatment of Patients in Need of Third Molar Removal and Oral Specimen Acquisition

The objective of this protocol is to evaluate and provide treatment for subjects who have a clinical indication for the routine extraction of dental third molar wisdom teeth with the aim to allow investigators to maintain their expertise in dental clinical care, gain additional knowledge about oral health and to utilize surgical waste collected from these patients for research studies. The protocol will enroll a convenience sample of 1000 subjects ages 18-50 in need of clinically indicated, routine extraction of third molars.

9. 12-D-0100 Niki Moutsopoulos, DMD-Oral Microbial and Immunological Characterization of Patients with Immune Dysfunction

This protocol is a cross sectional study designed to investigate the clinical, microbiologic, and immunologic consequences of immune dysfunction (particularly dysfunction due to primary immune defects) in the oral cavity. The hypothesis is that systemic immune dysfunction, attributed to monogenic immune defects in most of our populations of interest, will lead to alterations in the local immune response and microbial colonization and ultimately predispose to susceptibility to oral infections and inflammatory conditions. Of particular interest to this protocol is the susceptibility of select patient populations with immune dysfunction to periodontal disease. Whereas patients with hyper-immunoglobulin E syndrome (HIES) are an important focus of this research, enrollment will be open to a broader population, including monogenic immune defects such as leukocyte adhesion deficiency-1 (LAD-1), chronic granulomatous disease (CGD), as well as patients with defects in cytokine signaling. The primary aim of this protocol is to use modern methodologies to characterize the immune response and microbial colonization in the oral cavity in health and patients with primary immune defects. By particularly studying subjects with monogenic immune defects, we aim to increase the understanding of the role of specific immune molecules and pathways in the balance of host/microbial interactions on mucosal surfaces such as the oral cavity.

10. 12-H-0078 Pamela, Robey, PhD-Preliminary Assessment of Direct Intra-myocardial Injection of Autologous Bone Marrow-derived Stromal Cells on Patients Undergoing Revascularization for CAD with Depressed Left Ventricular Function

Many investigators now believe that bone marrow-derived stem cells or endothelial progenitor cells can be recruited to and incorporated into tissues undergoing neovascularization, including cardiac tissue. Stem cells which include hematopoietic stem cells (HSCs), endothelial progenitor cells (EPCs), mesenchymal stem cells / stromal stem cells (MSCs), myoblasts, and undifferentiated side population cells have been used as an alternative therapeutic strategy for ischemic cardiovascular diseases that cannot be treated by routine interventional approaches. In a porcine pre-clinical study we found that cells survived after intramyocardial injection and differentiated into vascular cells, smooth muscle or endothelial cells. Functional analysis of regional wall motion and ejection fraction demonstrated statistically significant improvement in function in cell treated animals after six weeks compared with baseline and sham controls. A variety of studies have been conducted in subjects with coronary artery disease using different cell types and routes of administration. This study will be the first of its kind to administer autologous BMSC via direct intramyocardial injection in a rigorous clinical trial in the U.S. The primary objective is to evaluate the safety and feasibility of direct intra-myocardial injection of autologous bone marrow stromal cells (BMSCs) in adult subjects undergoing coronary artery bypass graft (CABG) or transmyocardial revascularization (TMR).

11. 11-D-0094 Ilias Alevizos, DMD- A Randomized Within-subject, Double-blind, Placebo-controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects

Salivary gland dysfunction is one of the major manifestations of Sjögren’s syndrome (SS). Although inflammation is thought to play an important role in the exocrinopathy, the correlation between glandular dysfunction and inflammation is limited. Systemic anti-inflammatory therapies tested to date, such as tumor necrosis factor antagonists, have not been effective treatments for SS salivary hypofunction, raising doubts about inflammation being the sole cause of salivary gland dysfunction. However, none of these trials tested whether an antiinflammatory effect was achieved in glandular tissues. The primary objective is to determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects.

12. 11-D-0172 Ilias Alevizos, DMD- The pathogenesis and natural history of Sjögren’s Syndrome

Sjögren’s syndrome (SS) is an autoimmune disease characterized by chronic inflammation involving the exocrine glands. The cause and pathogenesis of Sjögren’s syndrome is still largely unknown. In a genetically predisposed individual various environmental factors, such as viral infections, may lead to epithelial cell activation and a protracted inflammatory response with features of autoimmunity. Autoreactive lymphocytes and autoantibodies are considered important in this process although the pathogenic role of any particular autoantibody is still undefined. Although inflammation may contribute to the exocrinopathy of SS, the relationship between inflammation and exocrine dysfunction is poorly understood. Moreover, the model does not explain many of the extraglandular manifestations of SS patients, such as fatigue. Further studies are needed to better understand the pathogenesis of SS. The primary objective of this study is to enable the collection of longitudinal clinical and laboratory data and biologic specimens to identify pathogenetic mechanisms of SS by careful clinical phenotyping of SS patients and Sjögren’s-like conditions over time and collection of biologic samples for concurrent and future laboratory studies related to the pathogenesis of Sjögren’s syndrome.

The protocol will enable the study of the genetic basis and the mechanistic aspects of immunologic and non-immunologic abnormalities of SS and their associations with various clinical phenotypes.

13. 10-D-0020 Janice Lee, DDS, MD, MS-The Molecular Anatomy of Oral Wound Healing

The overall objective of this pilot study proposal is to establish the gene and protein expression profiles during the early stages (1-6 days) of normal oral wound repair. By comparing these profiles with those of cutaneous wound healing, we may be able to identify molecules exclusive to oral wound repair that could represent biomarkers of the healing process or serve as new therapeutic targets in pathological wound healing and cancer. One specific hypothesis to be tested is that the level of expression of pro-inflammatory gene networks by wound-infiltrating keratinocytes constitutes the most significant difference between the human oral and cutaneous wound transcriptomes. The specific hypothesis has been developed from data obtained from our recent complementary oral and skin wound healing studies in animals (see below).

14. 10-D-0180 Silvio Gutkind, PhD-A Pilot Trial Targeting mTOR as a Novel Mechanism-Based Neoadjuvant Therapy for Head and Neck Cancer

The five-year survival rate for stage III/IV head and neck squamous cell carcinoma (HNSCC) has remained at approximately 50% for more than three decades. In HNSCC, the AKT-mTOR-pS6 pathway is aberrantly activated and promotes tumorigenesis and metastasis. Rapamycin is the most extensively studied mTOR inhibitor for which therapeutic daily oral dose and schedule, pharmacologic levels in blood, and safety have been established. Inhibition of mTOR by rapamycin causes the rapid apoptotic death of HNSCC tumor xenografts and decreases the tumor burden and prolongs the survival of mice harboring early and advanced oral and skin SCC lesions in a variety of experimental cancer models. Preliminary evidence suggests that mTOR inhibitors cause tumor shrinkage and improved tumor margins in HNSCC patients. The primary objectives are to evaluate the following for patients with HNSCC given rapamycin as neoadjuvant treatment prior to surgery whether therapeutic activities of rapamycin lead to inhibition of mTOR complexes, mTORC1 and mTORC2, as assessed by the change in levels of pS6 and pAkt473 measured by immunohistochemistry (IHC) in tumor samples and by Western blotting in peripheral blood mononuclear cells (PBMCs) and reduce tumor cell proliferation, as judged by IHC for Ki-67 in tumor samples and antitumor activity in terms of objective response.

15. 07-D-0016 Rachel Gafni, MD-Effects of PTH Replacement on Bone in Hypoparathyroidism

This study will treat hypoparathyroid individuals with synthetic human PTH 1-34 (HPTH) for up to 5 years, periodically assessing skeletal changes through biochemical markers and iliac-crest bone biopsies, which will allow for ultrastructural, cellular, and molecular analyses.
With respect to HPTH treatment, this study is a single group, within-subjects, repeated measures treatment trial. With respect to all bone biopsy analyses, the design is a parallel group design with each subject allocated to one of the 3 biopsy follow-up times: 1, 2 or 4 years after initiation of HPTH therapy. Post-baseline biopsy timing will be randomly assigned (1:1.2:1.4, respectively) to each subject, stratified by gender and by menopausal status, when relevant. Changes from baseline (time 0) to 1, 2 and 4-years will be compared. Subjects who were on conventional therapy in the former version of the protocol will also be randomized into the new study design. In contrast to new subjects, whose biopsy is performed at the end of the conventional care run-in period, the pre-conventional care biopsy will be used as the baseline for the those subjects entering the new design after having been on conventional care in the older protocol. Because it is not known with certainty what effects duration of time on conventional therapy will have on biopsy results, randomization will also be stratified on status of prior study participation. The subjects who were on HPTH therapy at the time of the protocol redesign are followed as a separate group under this protocol.

16. 06-D-0206 Ilias Alevizos, DMD-Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of AdhAQP1, an Adenoviral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals with Irradiation-Induced Parotid Salivary Hypofunction

The treatment of most head and neck cancer patients includes ionizing radiation (IR). Salivary glands in the IR field suffer irreversible damage. There is no conventional treatment available to correct this condition. Our research group has been developing the AdhAQP1 recombinant serotype 5 adenoviral (rAd5) vector based on the hypothesis that a replication deficient rAd5 vector is capable of safely transferring the human aquaporin-1 (hAQP1) cDNA to parotid glands of adult patients with IR-induced salivary hypofunction, resulting in an elevated salivary output, albeit transiently. Salivary glands have proven to be valuable gene transfer targets in numerous pre-clinical animal model studies (1-3). hAQP1, the archetypal water channel, is a plasma membrane protein that facilitates water movement across lipid bilayers (4). Rat and minipig studies have clearly shown that the AdhAQP1 strategy for restoring salivary flow to IR-damaged salivary glands is effective, and studies in rats, non-human primates and minipigs have shown that AdhAQP1 and similar rAd5 vectors are without significant untoward effects after salivary gland delivery. The purpose of this clinical protocol is to test the safety of AdhAQP1, with some measures of efficacy, in adult patients with established IR-induced parotid gland hypofunction. The targeted tissue site for the AdhAQP1 vector in the proposed study is a single parotid gland. In this Phase 1 dose-escalation study, safety will be evaluated using conventional clinical and immunological parameters. The primary outcome measure for biological efficacy will be parotid gland salivary output.

17. 01-D-0184 Michael Collins, MD-Evaluation and Treatment of Bone and Mineral Disorders

Human diseases are commonly manifested in the skeletal system. The skeleton may be the primary or secondary target of the disease and the disease may be congenital or acquired. While understanding of the molecular and cellular biology of bone and mineral disorders has increased in the last several years, much remains to be understood about the underlying biology of the skeleton. The gaps in the understanding of skeletal biology are evident in the paucity of tissue-specific therapies for skeletal diseases. Within this study, we plan to obtain tissue and cell specimens from outside institutions as well as to evaluate subjects with bone and mineral disorders at the NIH Clinical Center. Subjects will undergo clinically-indicated testing and possibly receive treatment, which will be limited to therapies based on the best professional judgment of the investigators and treatment with medications commercially available under FDA law.

18. 99-D-0070 Ilias Alevizos, DMD-Natural History of Salivary Gland Dysfunction and Sjögren's Syndrome

Saliva plays a major role in maintaining oral health and comfort. Saliva is needed to moisten the mouth, to lubricate food for easier swallowing, to protect oral hard and soft tissues, to modulate oral microbial populations, to provide enzymes necessary to begin food breakdown for digestion, and to promote soft tissue repair and oral cleansing. Therefore, salivary dysfunction may result in numerous clinical conditions affecting oral and systemic health, comfort and quality of life. In particular, we will focus on individuals with Sjögren's syndrome, an autoimmune exocrinopathy that primarily affects the salivary and lacrimal glands. A number of unanswered questions remain concerning salivary involvement in this disorder. These include the rate of progression of secretory dysfunction, and related oral and systemic complications associated with xerostomia in autoimmune and non-autoimmune diseases, and B-cell dysregulation. Also, more precise estimates of the incidence of the lymphoma development are needed. The purpose of this study is : 1) to allow careful follow-up of patients with defined salivary gland alterations so that the long term course and effects of Sjögren's syndrome (SS) on the oral cavity and systemic health in SS may be delineated; 2) to follow the development and progression of B-cell dysregulation in SS; 3) to follow subjects to establish whether those initially manifesting incomplete criteria for SS progress toward fully meeting the criteria.; 4) to refine diagnostic tests for SS, and to determine whether those subjects who meet the criteria for SS continue to do so; and 5) to develop intermediary outcome measures for SS based on long term outcomes (loss of tears and loss of stimulated salivary flow).

19. 98-D-0145 Michael Collins, MD-Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome

Polyostotic fibrous dysplasia (PFD) is a sporadic disorder which affects multiple sites in the skeleton. The bone at these sites is rapidly resorbed and replaced by abnormal fibrous tissue or mechanically abnormal bone. PFD may occur alone or as part of the McCune-Albright Syndrome (MAS), a syndrome originally defined by the triad of PFD, cafe-au-lait pigmentation of the skin, and precocious puberty. The bony lesions are frequently disfiguring and painful, and depending on the location of the lesion, can cause significant morbidity. Lesions in weight-bearing bones can lead to disabling fractures, while lesions in the skull can lead to compression of vital structures such as cranial nerves. The natural history of this disease is poorly described and there are no clearly-defined systemic therapies for the bone disease. The purpose of this study is to define the natural history of the disease with or without treatment.

20. 94-D-0018 Alevizos, DMD-Salivary Evaluation in Healthy Volunteers

Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation.

21. 84-D-0056 Ilias Alevizos, DMD-Evaluation of Salivary Gland Dysfunction

This study will evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.

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Last Reviewed
July 2018