Clinical Performance of Bulk-Fill Composite Using With Adhesives With or Without Chlorhexidine
- Conditions
- Class II Dental Caries
- Interventions
- Other: Class II Cavity Restorations
- Registration Number
- NCT06257108
- Lead Sponsor
- Uşak University
- Brief Summary
This study aims to evaluate the clinical success of chlorhexidine-containing dentin bonding agent in primary molars with a 12-month follow-up. The research question is:
Is there a difference between the clinical evaluation results of deciduous teeth restored with dentin bonding agents containing and not containing chlorhexidine?
A total of 40 patients aged 5-9 years with at least two dentin caries in primary molars were included in the study. The study involved a split-mouth design in which the standard bond and chlorhexidine-containing bond as the adhesive agents. Bulk Fill composite was used as the restorative material for the restoration of primary molars with class II cavity. The evaluation of clinical success was performed by a calibrated observer according to the FDI criteria at months 3, 6, 9, and 12 after restoration.
- Detailed Description
This study aims to evaluate the clinical success of chlorhexidine-containing dentin bonding agent in primary molars with a 12-month follow-up. A total of 40 patients aged 5-9 years with at least two dentin caries (D1 Level) in primary molars were included in the study. The study involved a split-mouth design in which Ultradent PQ1 Bond and Ultradent Peak Universal Bond were used as the bonding agents and Tetric N Ceram Bulk Fill composite was used as the restorative material for the restoration of primary molars with class II cavity. The evaluation of clinical success was performed by a calibrated observer according to the FDI criteria at months 3, 6, 9, and 12 after restoration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
(1) age between 5-9 years; (2) no systemic health problems (3) presence of at least one interproximal carious lesion not exceeding half of the dentin structure (D1 level) in the right and left sides of the mouth; (4) cooperation without issues (scoring 3 or 4 on the Frankl scale); and (5) patient and parent's willingness to attend follow-up appointments throughout the study.
- (1) the presence of pulp vitality with no clinical and/or radiological signs requiring endodontic treatment, (2) no previous treatment on the selected teeth, (3) Radiographically, the caries should not extend to one-third of the pulp, indicating only the need for a Class II restoration, (4) the presence of adjacent teeth mesial and distal to the selected tooth and an opposing tooth in the oral cavity, (5) the absence of physiological or pathological root resorption.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Restorative group Class II Cavity Restorations Class II restorations using chlorhexidine-containing bonding agent in Primary molars in children aged between 5-9 years. Control Group Class II Cavity Restorations Class II restorations using standard bonding agent in Primary molars in children aged between 5-9 years.
- Primary Outcome Measures
Name Time Method Clinical evaluation The treatments will be assessed using the same method over a 12-month period with 3-month intervals. Following the completion of the restorations, a proficient observer, unaware of the utilized material, will assess the respective tooth based on the World Dental Federation (FDI) criteria (reference). This evaluation will be conducted using a mirror and probe under illumination, with teeth being dried using air/water spray. The assigned scores will categorize the restorations as successful (Score 1), exhibiting minor defects (Score 2), showing acceptable defects (Score 3), needing repair (Score 4), or necessitating replacement (Score 5).
- Secondary Outcome Measures
Name Time Method