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36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite

NCT ID: NCT04679220

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Dental Leakage

Keywords

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Resin Composite Pain Randomized Clinical Trial Operative Dentistry Preheating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Non-heated Resin Composite group

Patients received Non-heated nanofilled resin composite on one side of the mouth

Group Type ACTIVE_COMPARATOR

Preheating

Intervention Type PROCEDURE

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

Preheated Resin Composite group

Patients received preheated nanofilled resin composite on the other side of the mouth

Group Type PLACEBO_COMPARATOR

Preheating

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36.MCEPRCRCL

Identifier Type: -

Identifier Source: org_study_id