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

Not Applicable

Not yet recruiting

• Conditions: Class V Dental Caries
• Interventions: Device: resin modified glass ionomer; Device: PRG barrier coat + nanohybrid composite

• Registration Number: NCT05605457
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-10-29
• Last Update Submitted: 2022-10-29
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Study Start: 2023-01
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin modified glass ionomer	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.
PRG barrier coat	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.

Primary Outcome Measures

Name	Time	Method
Modified USPHS criteria	18 months	Retention, marginal discoloration, marginal adaptation, secondary caries

Secondary Outcome Measures

Name	Time	Method
Modified USPHS criteria	18 months	Postoperative hypersensitivity