Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial

October 29, 2022 updated by: Nora Ahmed Salah, Cairo University
Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Class V carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat.Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 years Males or females. Patients with untreated cervical carious lesion that need restoration. Participants available for recall Patients with moderate to high caries risk

Teeth Inclusion Criteria No spontaneous pain Absence of tooth mobility

Exclusion Criteria:

  • Patients with para-functional habits Experience with allergic reactions against any component of used materials. Teeth Exclusion Criteria Non-vital teeth Teeth with orthodontic appliance Teeth with advanced periodontal diseases.

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: PRG barrier coat
It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.
Device: PRG barrier coat + nanohybrid composite
It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.
Active Comparator: Resin modified glass ionomer
Resin modified glass ionomer (Fuji II LC, GC, Japan). RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction.
Device: resin modified glass ionomer
RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified USPHS criteria
Time Frame: 18 months
Retention, marginal discoloration, marginal adaptation, secondary caries
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified USPHS criteria
Time Frame: 18 months
Postoperative hypersensitivity
18 months

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

October 29, 2022

First Submitted That Met QC Criteria

October 29, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

October 29, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG barrier coat liner Class V

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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