Preheated Composites Vs. Conventional Composites in Noncarious Cervical Lesions

NCT05533255 | Unknown

• 1 other identifier: MUCM/FOD/AR/B10/E C-2022 (04)
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Noncarious Cervical Lesions

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Preheated Resin Composites

EXPERIMENTAL

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 Resin Composites

ACTIVE COMPARATOR

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)

Interventions

Conventional composite resin (3M™ Filtek™ Z350 XT Universal Restorative) OTHER

Composite resin at room temperature is used.

Conventional Resin Composites

Preheated composite resin (3M™ Filtek™ Z350 XT Universal Restorative) OTHER

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.

Preheated Resin Composites

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manipal University College Malaysia: lead

Study Sites (1)

Manipal University College Malaysia

Malacca, 75150, Malaysia

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anchu R Thomas

CONTACT

+601127292297; rachel.thomas@manipal.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: September 8, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)