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

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04848987
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Dental Leakage	Procedure: Etching	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies
• Actual Study Start Date: Oct 10, 2016
• Actual Primary Completion Date: Oct 10, 2016
• Actual Study Completion Date: Sep 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percentage % of patients with marginal staining [5 years after restoration procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT04848987
• Other Study ID Numbers: A10150421
• First Posted: Apr 19, 2021
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mansoura University: Resin Composite; Randomized Clinical Trial; Operative Dentistry
• Additional relevant MeSH terms: Dental Leakage

Study Results

No Results Posted as of Apr 19, 2021