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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04679220
Other study ID # 36.MCEPRCRCL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 30, 2020

Study information

Verified date December 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.


Description:

The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 30, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - Patients with primary caries involving occlusal surface only with ICDAS 2 and 3 - Patients with cavities no more than one-third of the intercuspal distance - Patients must have a good oral hygiene; - Patients with tooth gives positive response to testing with an electric pulp tester - Patients with normal and full occlusion, - Patients with opposing teeth should be natural with no restorations. Exclusion Criteria: - High caries risk patients with extremely poor oral hygiene, - Patients involved in orthodontic treatment or periodontal surgery, - Patients with periodontally involved teeth (chronic periodontitis) - Patients with abutments should be excluded. - Patients with heavy bruxism habits and clenching

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Preheating
For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites

Locations

Country Name City State
Egypt Faculty of Dentistry Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage % of patients with marginal staining Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor) 3 years after restoration procedure
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