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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05605457

Enrollment

Registered

2022-11-04

Start date

2023-01-31

Completion date

2024-08-31

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class V Dental Caries

Keywords

PRG barrier coat, nanohybrid resin composite, Resin modified glass ionomer

Brief summary

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.

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.

Interventions

DEVICEPRG 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.

DEVICEresin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Modified USPHS criteria	18 months	Retention, marginal discoloration, marginal adaptation, secondary caries

Secondary

Measure	Time frame	Description
Modified USPHS criteria	18 months	Postoperative hypersensitivity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026