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

Not Applicable

Completed

• Conditions: Class V Dental Caries
• Interventions: Device: Resin modified glass ionomer; Device: Giomer based injectable resin composite

• Registration Number: NCT05389163
• Lead Sponsor: Cairo University

Brief Summary

Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.

Detailed Description

In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Start: 2022-07-17
• Primary Completion: 2024-04-05
• Status Verified: 2024-07
• Study Completion: 2024-07-04
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin modified glass ionomer	Resin modified glass ionomer	Fuji II LC, GC
Giomer based injectable resin composite	Giomer based injectable resin composite	Beautifil Flow plus X F03, SHOFU, USA

Primary Outcome Measures

Name	Time	Method
Clinical performance (Marginal adaptation)	18 months	Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.; Alpha is the best outcome and charlie is the worse outcome .

Secondary Outcome Measures

Name	Time	Method
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)	18 months	Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.; Alpha is the best outcome and charlie worse outcome .

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt