Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)
Launched by MAHIDOL UNIVERSITY · Oct 7, 2022
Trial Information
Current as of July 03, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new type of dental adhesive called a 2-steps universal adhesive, specifically for individuals with non-carious cervical lesions (NCCL). These lesions are areas of wear or damage on the teeth that aren’t caused by cavities. The main goal of the study is to see how well this new adhesive works when applied using different techniques for preparing the tooth surface. Participants will receive dental restorations using this adhesive while trying out one of three methods of etching the tooth: etch-and-rinse, selective enamel etching, or self-etch.
To join the trial, participants need to be between the ages of 65 and 74, have at least 28 teeth (or 20 that are functioning properly), and have at least three non-cavity cervical lesions that are not close to the pulp (the inner part of the tooth). They should also be able to come in for follow-up visits. However, people with serious dental issues, those who smoke heavily, or those with certain health conditions may not be eligible. Participants can expect to have their dental restoration done and monitored over time to see how well the adhesive performs. This study is currently recruiting, and it’s a great opportunity to contribute to understanding better dental treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Available for follow-up visits
- • Have at least 28 teeth/ 20 teeth under occlusion
- • Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.
- Exclusion Criteria:
- • Rampant / uncontrolled caries
- • Advanced untreated periodontal disease
- • \>2 cigarette packs/day
- • Systemic or local disorders that could not undergo dental procedures
- • Xerostomia
- • Severe bruxism, clenching, TMD
- • Pregnancy at the time of screening
- • Known history of sensitivity to resin or related materials
- • Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years
About Mahidol University
Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, , Thailand
Patients applied
Trial Officials
Pipop Saikaew, PhD
Principal Investigator
Faculty of Dentistry, Mahidol University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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