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

U

Uşak University

Status

Completed

Conditions

Class II Dental Caries

Treatments

Other: Class II Cavity Restorations

Study type

Interventional

Funder types

Other

Identifiers

NCT06257108
01.04.2015/76

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

5 to 9 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

40 participants in 2 patient groups

Restorative group
Experimental group
Description:
Class II restorations using chlorhexidine-containing bonding agent in Primary molars in children aged between 5-9 years.
Treatment:
Other: Class II Cavity Restorations
Control Group
Active Comparator group
Description:
Class II restorations using standard bonding agent in Primary molars in children aged between 5-9 years.
Treatment:
Other: Class II Cavity Restorations

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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