Preheated Composites Vs. Conventional Composites in Noncarious Cervical Lesions

Clinical Evaluation of Preheated Resin Composites Compared With Conventional Resin Composites in the Treatment of Noncarious Cervical Lesions - A Randomised Controlled Trial

Preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. Preheating increases the flow properties and allows better adaptation to cavity preparation. The high thermal energy also improves polymerization rate, thereby reducing microleakage. Conventional composites resin is used as one-paste light-cured systems, which are built up in increments to overcome the effects of setting shrinkage and to ensure thorough curing.

Several studies report failure of cervical restorations of noncarious cervical lesions and an incessant search for the most suitable restorative material. Therefore, this study aims to evaluate the clinical performance of conventional resin composites compared with preheated resin composites in the treatment of noncarious cervical lesions. Our null hypothesis states that there is no difference between the clinical performance of preheated resin composites and conventional resin composites in the treatment of noncarious cervical lesions.

This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-six randomly selected patients with two similar noncarious cervical lesions, each on a canine, first premolar, second premolar or first molar on the contralateral side of the maxillary arch. One lesion will be restored with preheated resin composite (3M™ Filtek™ Z350 XT Universal Restorative) while the other lesion will be restored with conventional resin composite (3M™ Filtek™ Z350 XT Universal Restorative). Both restorations will be done on each patient's first visit. The patients will be recalled 1,3 and 6 months later for assessment of the restorations, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and postoperative sensitivity.

Study Overview

• Status: Recruiting
• Conditions: Noncarious Cervical Lesions
• Intervention / Treatment: Other: Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative); Other: Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative)

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anchu R Thomas; Phone Number: +601127292297; Email: rachel.thomas@manipal.edu.my

Study Locations

• Malaysia
  • Melaka, Malaysia, 75150
    • Recruiting
    • Manipal University College Malaysia
    • Contact: Anchu R Thomas; Phone Number: +601127292297; Email: rachel.thomas@manipal.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are systemically healthy (ASA I and ASA II )44 and have satisfactory oral hygiene (OHI-S score of 0 to 3.0).
• Participants must have two noncarious cervical lesions (abrasion/abfraction), each on a canine, 1st premolar, 2nd premolar or 1st molar on the contralateral side of same dental arch (maxillary arch) with similar depth and width.
• Both NCCLs are in contact with antagonist teeth as well.

Exclusion Criteria:

• Participants requiring dental prostheses of the target teeth.
• Participants have a diagnosis of caries coincident with the cervical lesion, or an indication for irreversible endodontic treatment of the target teeth.
• Existence of periodontal damage with respect to the target teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preheated Resin Composites; Preheated resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on either one quadrant of the maxillary arch.	Other: Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative); Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) is preheated to a temperature of 57 degrees Celsius using a composite warmer for 10 minutes is used.
Active Comparator: Conventional Resin Composites; Conventional resin composite is placed on the noncarious cervical lesion of a canine/ first premolar/ second premolar/ first molar on the other quadrant of the maxillary arch.	Other: Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative); Composite resin at room temperature is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite	The restorations are evaluated using the modified US Public Health Service (USPHS) criteria	1 month
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite	The restorations are evaluated using the modified US Public Health Service (USPHS) criteria	3 month
Clinical Evaluation of Preheated Resin Composite Compared with Conventional Resin Composite	The restorations are evaluated using the modified US Public Health Service (USPHS) criteria	6 month

Collaborators and Investigators

• Sponsor: Manipal University College Malaysia
• Investigators: Principal Investigator: Sy Ying Heng, Manipal University College Malaysia; Principal Investigator: Sze Yee Tan, Manipal University College Malaysia; Principal Investigator: Chi Rou Tee, Manipal University College Malaysia; Principal Investigator: Krystell Chiu Yan Lau, Manipal University College Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 16, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Z 350
• Other Study ID Numbers: MUCM/FOD/AR/B10/E C-2022 (04)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No