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

NCT06257108 | Completed

• 1 other identifier: 01.04.2015/76
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Class II Dental Caries

Keywords

Dentin bonding agents; chlorhexidine; antibacterial bonding; bulk-fill composite

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Restorative group

EXPERIMENTAL

Class II restorations using chlorhexidine-containing bonding agent in Primary molars in children aged between 5-9 years.

Other: Class II Cavity Restorations

Control Group

ACTIVE COMPARATOR

Class II restorations using standard bonding agent in Primary molars in children aged between 5-9 years.

Other: Class II Cavity Restorations

Interventions

Class II Cavity Restorations OTHER

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.

Control Group; Restorative group

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Uşak University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: January 15, 2016
• Primary Completion: December 15, 2019
• Study Completion: April 15, 2024
• Last Updated: April 23, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share