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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Other: BRIX3000®; Other: Riva Star Aqua, SDI Limited, Australia

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sotiria Gizani, Assoc Prof; Phone Number: 2107461233; Email: sotiriagizani@gmail.com
• Study Contact Backup: Name: Kyriaki Seremidi, Assist Prof; Email: kseremid@uoa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success	Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.	6 and 12 month post-treatment
radiographic success	Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.	12 month post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient's acceptance	intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)	immediately post-treatment

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Sotiria Gizani, Assoc Prof, Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: NKUA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No