Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children

PHASE3RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

April 30, 2025

Conditions
White Spot Lesion of Tooth
Interventions
DRUG

Self-assembling peptide (P11-4)

"Prior to application, teeth are isolated by cotton rolls and gently air dried. The surface of the lesion is conditioned with a 2% sodium hypochlorite solution for 20 s and then rinse with water. Application of 35% phosphoric acid etching gel for 20 sec followed by rinsing with water-air spray for 30 sec. Drying the surface with compressed oil-free air for 60 sec. Curodont Repair is dissolve in 0.05 ml of distilled water and applied to the surface and allowed to work for about 5 min.~Participants will receive oral hygiene instructions."

DRUG

CPP-ACFP

"Prior to application, teeth are isolated by cotton rolls and gently air dried. Application of fluoride varnish with a brush applicator on the surface of the teeth for 5 minutes. Patients is advising not to brush their teeth or chew food for at least 4 h after treatment.~Participants will receive oral hygiene instructions"

DRUG

Resin infiltration

The validated ICON Vestibular (DMG) infiltration lesion infiltration protocol is applied. Icon Etch (DMG) etching gel containing 15% hydrochloric acid is applied for 120 seconds using an applicator. It is then removed by rinsing thoroughly with water-air spray for 30 seconds. Then follows application of pure alcohol - Icon Dry (DMG) for 30 seconds for complete drying of the lesion and additional drying compressed oil-free air for 40 sec. Application of Icon Infiltrant (DMG) using a microapplicator allows it to penetrate for 3 minutes, during which, if necessary, it is reapplied several times. Excess material is removed with dry microbrushes and followed by light curing for 40 seconds. Re-applying of the infiltrate for 1 minute, removal of excess material, light curing for 40 seconds. Participants will receive oral hygiene instructions

OTHER

Control Group, No Treatment

Everyday oral hygiene instructions Subjects will receive non-prescription fluoride toothpaste (1400 ppm Fluoride, Elmex junior) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate and rinse.

Trial Locations (1)

4000

RECRUITING

Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Plovdiv

All Listed Sponsors
lead

Plovdiv Medical University

OTHER