Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART

• Status: Completed
• Trial end date: 2019-11-17
• Target enrollment: 0
• Participant gender: All

Summary

The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marina F Fahmy, MD
• Treatments: Fluorides

Criteria

Inclusion Criteria:

1. Children aged from 4 to 8 years old, in good general health

2. Children classified as class 3 or 4 based on Frankel et al. classification. (26)

3. The children have at least one primary molar with class I carious lesion.

4. Asymptomatic teeth (without spontaneous pain)

Exclusion Criteria:

1. Medically compromised patient

2. Presence of pulp exposure, pain, mobility

3. Presence of swelling, abscess or fistula near the tooth

4. Not accessible carious lesion to hand instruments