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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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.
|
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.
|
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
Time Frame: 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).
|
The treatments will be assessed using the same method over a 12-month period with 3-month intervals.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01.04.2015/76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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