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

Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies

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?

Study Overview

• Status: Completed
• Conditions: Dental Leakage
• Intervention / Treatment: Procedure: Etching

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Etch-and-rinse (Variolink N) resin cement; For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement.	Procedure: Etching; Etching enamel surface using phosphoric acid
Placebo Comparator: Self-etch (Panavia F2.0) resin cement; Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement.	Procedure: Etching; Etching enamel surface using phosphoric acid
No Intervention: Self-adhesive (RelyX Unicem) resin cement; For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Resin Composite; Operative Dentistry
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Leakage
• Other Study ID Numbers: A10150421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study Protocol, Statistical Analysis Plan can be shared to other researchers
• IPD Sharing Time Frame: Data will be available within 3 Months for 5 years
• IPD Sharing Access Criteria: For anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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