Arresting Carious Lesions With Minimal Intervention Techniques

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388746
• Other study ID #: NKUA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: National and Kapodistrian University of Athens
• Contact: Sotiria Gizani, Assoc Prof
• Phone: 2107461233
• Email: sotiriagizani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success	Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.	6 and 12 month post-treatment
Primary	radiographic success	Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.	12 month post-treatment
Secondary	Longevity and the quality of the final restoration	Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria.	6 and 12 months post-treatment
Secondary	Patient's acceptance	intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)	immediately post-treatment