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NCT Number: NCT04679220

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

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.

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Key information

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preheating

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

Primary outcomes

  1. Percentage % of patients with marginal staining

    Time frame: 3 years after restoration procedure

    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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

36-Months Clinical Evaluation of Preheated Resin Composite

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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