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NCT Number: NCT04848987

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

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?

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Key information

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etching

Procedure

Etching enamel surface using phosphoric acid

Primary outcomes

  1. Percentage % of patients with marginal staining

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies

Important dates

Study start
2016
Primary completion
2016
Study completion
2020
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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