Rct Deep Margin Elevation by Self Adhesive Composite

Launched by CAIRO UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to a dental procedure called Deep Margin Elevation (DME). The goal is to test a new type of filling material called FIT SA™, which is a self-adhesive composite that makes the DME process simpler and more efficient. Unlike traditional methods, this new material doesn’t require a complicated bonding step, which can be tricky for dentists. It is designed to work well in hard-to-reach areas of the mouth, reducing problems like saliva or blood interfering with the procedure. The trial aims to see how effective this new material is in treating cavities located near the gums.

To participate in this study, volunteers should be between 21 and 45 years old, have certain types of cavities (specifically, moderate caries with certain severity scores), and must be able to commit to a one-year follow-up period. However, individuals with poor oral hygiene, those undergoing orthodontic treatment, or anyone with specific dental issues like prolonged tooth pain will not be eligible. Participants will receive the new filling material and will be monitored for any effects or improvements over the next year. This study represents an exciting opportunity to help improve dental care techniques and outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients accept the one year follow up period. Cooperative patients. The study recruited volunteers of both genders Age from 21 to 45 years Primary compound proximal caries, with International Caries Detection and Assessment System (ICDAS) scores of 4 or 5.
• • The buccolingual width of the lesion could not exceed two-thirds of the intercuspal distance.
• • The remaining dentin thickness not less than 1 mm from the pulp and that could be identified clinically and by periapical xray Vital teeth without any signs of radiolucency in the periapical or furcation areas.
• • Participants also had to present a moderate risk of caries.
• Exclusion Criteria:
• • Those who requiring any form of pulp capping will excluded to differentiate postoperative hypersensitivity from pulpal inflammation.
• • Individuals with poor oral hygiene. Patients undergoing orthodontic treatment. Periodontal surgery patients. Smokers. Pregnant women. Patients without occlusal contact. Those suffering prolonged tooth pain that disrupted sleep.