Clinical Trials Program
Overview
The National Institute of Dental and Craniofacial Research (NIDCR) is committed to identifying effective preventive, diagnostic, and treatment approaches for dental, oral, and craniofacial diseases and disorders. To advance these efforts, the institute supports well-designed and well-executed clinical trials (Phase I, II, III, and IV) that test interventions with the potential to improve dental, oral, and craniofacial health. These trials should provide scientific evidence that can be used for establishing or changing the standard of care, or for consideration of a change in health care policy. To be eligible for NIH funding, all clinical research involving investigational drugs, biologics, devices, or other products regulated by the U.S. Food and Drug Administration (FDA) must comply with all applicable FDA requirements. Examples of supported research include:
- Clinical trials testing the safety, efficacy, or effectiveness of new preventive or treatment therapies for dental, oral, or craniofacial diseases (e.g., dental caries, periodontal diseases, head and neck cancer, orofacial pain conditions, and salivary gland dysfunction)
- Conducting comparative safety and effectiveness studies of dental, oral, or craniofacial disease treatments
- Clinical trials testing the ability of diagnostic criteria, reliable markers, oral biosensors/biodevices, and/or imaging techniques to diagnose and assess the onset and progression of dental, oral, or craniofacial diseases
- Clinical trials testing the safety, efficacy, or effectiveness of tissue regeneration therapies to repair or replace dental, oral, or craniofacial tissues
- Clinical trials testing the safety, efficacy, or effectiveness of therapies to prevent or treat dental, oral, or craniofacial sequelae of systemic treatments in individuals with chronic or medically complex conditions