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

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.

Study Overview

• Status: Completed
• Conditions: Class II Dental Caries
• Intervention / Treatment: Other: Class II Cavity Restorations

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restorative group; Class II restorations using chlorhexidine-containing bonding agent in Primary molars in children aged between 5-9 years.	Other: Class II Cavity Restorations; The study involved a split-mouth design in which Ultradent PQ1 Bond (standard bond) and Ultradent Peak Universal Bond (chlorhexidine-containing 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.
Active Comparator: Control Group; Class II restorations using standard bonding agent in Primary molars in children aged between 5-9 years.	Other: Class II Cavity Restorations; The study involved a split-mouth design in which Ultradent PQ1 Bond (standard bond) and Ultradent Peak Universal Bond (chlorhexidine-containing 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The treatments will be assessed using the same method over a 12-month period with 3-month intervals.

Collaborators and Investigators

• Sponsor: Uşak University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chlorhexidine; Dentin bonding agents; antibacterial bonding; bulk-fill composite
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 01.04.2015/76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there are no plans to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No