Arresting Carious Lesions With Minimal Intervention Techniques
- Conditions
- Caries,Dental
- Interventions
- Other: BRIX3000®Other: Riva Star Aqua, SDI Limited, Australia
- Registration Number
- NCT06388746
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Caries removal group BRIX3000® 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. Caries arrest group Riva Star Aqua, SDI Limited, Australia 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.
- Primary Outcome Measures
Name Time Method clinical success 6 and 12 month post-treatment Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.
radiographic success 12 month post-treatment Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.
- Secondary Outcome Measures
Name Time Method Patient's acceptance immediately post-treatment intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)
Longevity and the quality of the final restoration 6 and 12 months post-treatment Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria.