Clinical trial NCT04679220: 36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite
Official title: 36-Months Clinical Evaluation of Preheated Resin Composite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Leakage
Keywords: Resin Composite
Pain
Randomized Clinical Trial
Operative Dentistry
Preheating
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage % of patients with marginal staining
timeFrame: 3 years after restoration procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
state: Dakahlia
Study officials:
References: