Arresting Carious Lesions With Minimal Intervention Techniques

NCT ID: NCT06388746

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Caries removal group

Cavitated lesion will be isolated with cotton rolls and air-dried. Gel will be placed in the cavity and kept there for 60 seconds to allow for the decayed tissue to become softer. The softened tissue will be removed with a hand instrument. The gel will be reapplied, until complete removal of the carious tissue is achieved. Teeth will be restored using a high viscosity glass ionomer cement.

Group Type: EXPERIMENTAL

BRIX3000®

Intervention Type: OTHER

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.

Caries arrest group

Cavitated lesion will be isolated with cotton rolls and air-dried. One drop of component 1 (38% Silver Fluoride (AgF) in water) will be applied for 60 seconds using a microbrush, followed by two drops of component 2 (potassium iodide) for 90 seconds. Teeth will be restored using a high viscosity glass ionomer cement.

Group Type: ACTIVE_COMPARATOR

Riva Star Aqua, SDI Limited, Australia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.

Exclusion Criteria

• Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Sotiria Gizani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sotiria Gizani, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens

Central Contacts

Sotiria Gizani, Assoc Prof

Role: CONTACT

sotiriagizani@gmail.com

2107461233

Kyriaki Seremidi, Assist Prof

Role: CONTACT

kseremid@uoa.gr

Other Identifiers

NKUA

Identifier Type: -

Identifier Source: org_study_id