Clinical Performance of Bulk-Fill Composite Using With Adhesives With or Without Chlorhexidine

Uşak University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: (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. Exclusion Criteria: * (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.

Outcomes

Primary Outcomes

Clinical evaluation

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).

Time frame: The treatments will be assessed using the same method over a 12-month period with 3-month intervals.