Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult With Class V Carious

Not Applicable

• Conditions: Cervical Lesion
• Interventions: Other: Resin Modified Glass Ionomer; Other: Alkasite bioactive restorative material.

• Registration Number: NCT04716517
• Lead Sponsor: Cairo University

Brief Summary

Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.

Detailed Description

In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. 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, 12 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) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.

The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-16
• Study First Posted: 2021-01-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Study Start: 2021-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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	Comparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients.
Cention N	Alkasite bioactive restorative material.	Intervention Alkasite Restoration will be used to restore cervical carious in adult patients.

Primary Outcome Measures

Name	Time	Method
(Marginal adaptation)	12 months	(USPHS) criteria

Secondary Outcome Measures

Name	Time	Method
Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)	12 months	(USPHS) criteria