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

NCT04679220 | Completed

• 1 other identifier: 36.MCEPRCRCL
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Leakage

Keywords

Resin Composite; Pain; Randomized Clinical Trial; Operative Dentistry; Preheating

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Non-heated Resin Composite group

ACTIVE COMPARATOR

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

Procedure: Preheating

Preheated Resin Composite group

PLACEBO COMPARATOR

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

Procedure: Preheating

Interventions

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

Non-heated Resin Composite group; Preheated Resin Composite group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Dental Leakage; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 22, 2020
• Study Start: October 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 3 Months for 3 years
• Access Criteria: for anyone

Locations

EG (1)