Effect of Aging on Micro-tensile Bond Strength and Color Stability of Self-adhesive Resin Composite

June 12, 2024 updated by: Nourhan Samir Soliman Ibrahim, Minia University

Evaluation of Micro -Tensile Bond Strength to Dentin and Color Stability of a New Self Adhesive Bulk-fill Resin Composite Restorative Material After Aging

The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Minya, Egypt, 61519
        • Recruiting
        • Faculty of Dentistry, Minya University.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wael E Jamil, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.
  • Patients with teeth shade A2 according to Vitapan classical shade guide.
  • Patients with an acceptable oral hygiene level.
  • Patients keen to regularly attend the follow up visits.

Exclusion Criteria:

  • Patients with heavy bruxism or traumatic occlusion.
  • Patients with poor oral hygiene or active periodontal disease.
  • Patients with exposed or endodontically treated teeth.
  • Patients participated in a clinical trial within 6 months before beginning of this trial.
  • Patients who decline to be involved in the study or sign the written consent.
  • Patients unable to return for the follow up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surefil one bulk-fill composite
Restorative material applied directly to the tooth without adhesive appliaction.
Other: self-adhesive resin restoration
Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage
Other Names:
  • Surefil one
Active Comparator: Filtek One bulk-fill composite
Restorative material that is applied to the tooth after adhesive application.
Other: self-adhesive resin restoration
Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage
Other Names:
  • Surefil one

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.
Time Frame: 6 months
Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Director: Wael Essam Jamil, Professor, Faculty of Dental Medicine for Girls, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • self-adhesive resin composite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Name Faculty Country

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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