Center for Clinical Research, DER, NIDCR
Objective
Some systemic diseases and syndromes significantly impact oral health, and patients with these conditions are often managed with more frequent and aggressive dental treatment protocols. However, most of the evidence supporting these management strategies comes from clinical trials that enrolled healthy subjects, longitudinal studies with limited follow-up periods, or case report and case series. The purpose of this initiative is to stimulate research to address gaps in our knowledge of how best to treat oral diseases of patients with systemic diseases or conditions known to compromise oral health, to identify factors predictive of treatment outcomes within patient groups, and to generate evidence for more precise dental treatment guidelines that are tailored to patient needs. To capture longer term outcomes, research proposals must study established cohorts of individuals with the disease of interest, in representative populations of sufficient size to obtain meaningful results.
Background
Systemic diseases and syndromes such as Sjögren's syndrome, cleft lip/palate, ectodermal dysplasias (ED), osteogenesis imperfecta (OI), head and neck cancer, diabetes, dementia, and normal aging in older adults compromise oral health. Oral diseases are more prevalent and severe in affected individuals, who can spend significant time and resources maintaining their oral health. A case-control study of Sjögren's syndrome patients found out-of-pocket spending for dental care was two to three-fold higher in Sjögren's patients as compared with peer controls. However, there are very few clinical studies examining the success of various dental treatments in Sjögren's. Further, some systemic diseases can increase the risk for bleeding, infection, and slower wound healing, which may complicate dental treatment. Most treatment guidelines for managing caries, periodontal diseases or malocclusions are derived from clinical trials/studies in relatively healthy subjects, and the long term successes of different treatment and restorative approaches for oral diseases in medically complex patients are not known. Practitioners treating certain patient populations have called for more research to guide their treatment decisions. For example, a recent meeting of dental specialists at the medical advisory board for osteogenesis imperfecta reinforced the need for evidence-based treatment guidelines for those with severe, unique malocclusions and dentinogenesis imperfecta, as current recommendations are often based on expert opinion.
Knowledge gaps exist in dental treatment guidelines for several systemic diseases long known to impact oral health. While there has been significant research characterizing periodontitis in type 2 diabetes (T2D), there are far fewer studies of oral health in adults with type 1 diabetes (T1D), a population that is growing as the life span of those with T1D increases. Several rarer systemic diseases that impact oral health have been characterized through careful phenotyping and genotyping in the last 15 years, but there have been limited studies focused on outcomes of dental treatment for their unique diseases. Outcomes research supported by this initiative will help establish evidence-based dental treatment guidelines for patients with disease- or syndrome-related compromised oral health, to suggest appropriate adaptations (in timing, frequency, procedure or material) of recommended preventive, restorative, and treatment approaches.
Alignment with Institute Goals and Strategic Plan
Historically, there has been very little robust clinical research regarding dental treatment outcomes in patients with systemic diseases and disorders known to impact oral health, despite the increased knowledge about the genetic background and clinical phenotype. The objective of this initiative is consistent with the NIDCR Strategic Plan 2014–2019: Objective 1-3: Conduct translational and clinical investigations to improve dental, oral, and craniofacial health; and Objective 2-1: Support research toward precise classification, prevention, and treatment of dental, oral, and craniofacial health and disease. Since complex medical patient groups include older adults, individuals with dementia, post head and neck radiation patients, individuals with primary Sjögren's syndrome, individuals born with cleft lip/palate or individuals with rare syndromes such as the ectodermal dysplasias and osteogenesis imperfecta, this initiative would encourage formation of interdisciplinary research teams with the required expertise to conduct high quality studies.
Feasibility
This concept is an opportunity to conduct clinical research to address significant knowledge gaps about treatment of oral diseases in those with disorder or disease-related compromised oral health. There are several large ongoing longitudinal cohort studies sponsored by the various NIH Institutes and Centers such as the Rare Diseases Clinical Research Networks that are ideal for this type of outcomes research. Outcomes currently collected by these consortia investigators include responses to therapies for their systemic disease (effectiveness research), making these well-characterized cohorts ideal for collection of dental treatment outcomes. Other existing cohorts with adequate populations are available within specialized academic centers, patient advocacy groups for specific disorders, and long-term care facilities for older adults. Registries have been established by patient organizations, such as the National Foundation for Ectodermal Dysplasias, which could be used to rapidly recruit subjects for studies.
Current Portfolio Overview
The NIDCR currently supports a small cluster of projects (in response to DE-12-006 and DE-12-007, Effectiveness of Treatment for Oral Diseases in Medically Compromised Patients) addressing: a) long-term outcomes of dental implants in diabetic subjects, b) surgical and speech outcomes in cleft lip/palate subjects, c) dental outcomes in head and neck cancer patients and d) dental and surgical outcomes in fibrous dysplasia/McCune-Albright syndrome.
References
American Academy of Pediatric Dentistry, Council of Clinical Affairs. Guidelines on Dental Management of Heritable Dental Developmental Anomalies, 2013. http://www.aapd.org/media/Policies_Guidelines/G_OHCHeritable.pdf (PDF - 206 KB)
Connor J, Olear EA, Insogna KL, Katz L, Baker SD, Simpson CA, Sterpka j, Dubrow R, Zhang JH, Carpenter TO. Conventional therapy in adults with x-linked hypophosphatemia: effects on enthesopathy and dental disease. J Clin Endocrinol Metab 2015 Jul15; JC20152199 [Epub ahead of print]
McNally M, Martin-Misener R, McNeil K, Briliant M, Moorhouse P, Crowell S, Matthews D, Clovis J. Implementing oral care practices and policy into long-term care: the Brushing up on Mouth Care project. J Am Med Dir Assoc 2015 Mar; 16(3): 200-7.
Oates TW Jr, Galloway P, Alexander P, Vargas Green A, Huynh-Ba G, Feine J, McMahan CA. The effects of elevated hemoglobin A(1c) in patients with type 2 diabetes mellitus on dental implants: Survival and stability at one year. J Am Dent Assoc 2014 Dec; 145(2): 1218-26.
Segal B, Bowman SJ, Fox PC, Vivino FB, Murukutla N, Brodscholl J, Ogale S, McLean L. Primary Sjögren's Syndrome: health experiences and predictors of health quality among patients in the United States. Health Qual Life Outcomes. 2009 May 27;7:46. doi: 10.1186/1477-7525-7-46.
Steck AK, Vehik K, et al. Predictors of progression from the appearance of islet autoantibodies to early childhood diabetes: The Environmental Determinants of Diabetes in the Young (TEDDY). Diabetes Care. 2015 May;38(5):808-13.