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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.

NCT05389163

Class V Dental Caries

COMPLETED NA

Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems

NCT06543680

Secondary Caries Dental Restoration Failure of Marginal Integrity

RECRUITING NA

Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year

NCT05617703

Dental Caries Class v

UNKNOWN NA

Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

NCT06185881

Cervical Caries

COMPLETED NA

Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation

NCT06497231

Deep Caries Dental Caries

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Class V Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PRG barrier coat + nanohybrid composite

Intervention Type DEVICE

It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.

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.

Group Type ACTIVE_COMPARATOR

resin modified glass ionomer

Intervention Type DEVICE

RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes