NCT06388746

Arresting Carious Lesions With Minimal Intervention Techniques

Minimal Intervention Techniques for Arresting Caries in Primary Molars: a Randomized Clinical Trial With 12 Months Follow-up.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.

Detailed description

Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers. Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement. Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.

Conditions

• Caries,Dental

Interventions

Type	Name	Description
OTHER	BRIX3000®	A gel that when applied to the tooth completely removes carious tissues in a chemo mechanical way without rotary instruments. It contains an enzyme that has bactericidal, bacteriostatic and anti-inflammatory properties and proteolytic properties that help soften and break down decayed tissue without destroying the underlying healthy collagen fibers.
OTHER	Riva Star Aqua, SDI Limited, Australia	A solution that contains 44,800 ppm F and 253,870 ppm Ag. It acts as a fluoride storage for the acid challenges, while inhibites demineralization of hydroxyapatite crystals and preserves collagen from degradation in demineralized tissues.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-04-29
• Last updated: 2024-04-29