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

NCT ID: NCT04848987

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2020-09-10

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?

Detailed Description

Objective: 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.

Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.

Conditions

Dental Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Etch-and-rinse (Variolink N) resin cement

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

Group Type: ACTIVE_COMPARATOR

Etching

Intervention Type: PROCEDURE

Etching enamel surface using phosphoric acid

Self-etch (Panavia F2.0) resin cement

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

Group Type: PLACEBO_COMPARATOR

Etching

Intervention Type: PROCEDURE

Etching enamel surface using phosphoric acid

Self-adhesive (RelyX Unicem) resin cement

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Etching

Etching enamel surface using phosphoric acid

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A10150421

Identifier Type: -

Identifier Source: org_study_id