Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement

NCT04848987 | Completed

• 1 other identifier: A10150421
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years. The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?

Conditions

Dental Leakage

Keywords

Resin Composite; Randomized Clinical Trial; Operative Dentistry

Outcome Measures

Primary Outcomes (1)

• Percentage % of patients with marginal staining

  Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.

  5 years after restoration procedure

Study Arms (3)

Etch-and-rinse (Variolink N) resin cement

ACTIVE COMPARATOR

For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement.

Procedure: Etching

Self-etch (Panavia F2.0) resin cement

PLACEBO COMPARATOR

Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement.

Procedure: Etching

Self-adhesive (RelyX Unicem) resin cement

NO INTERVENTION

For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement.

Interventions

Etching PROCEDURE

Etching enamel surface using phosphoric acid

Etch-and-rinse (Variolink N) resin cement; Self-etch (Panavia F2.0) resin cement

Eligibility Criteria

• Age: 20 Years - 35 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

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 19, 2021
• Study Start: October 10, 2016
• Primary Completion: October 10, 2016
• Study Completion: September 10, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 3 Months for 5 years
• Access Criteria: For anyone

Locations

EG (1)