Hema Free Versus Hema Containing Adhesives in Posterior Restorations

Not Applicable

Active, not recruiting

• Conditions: Dental Caries
• Interventions: Procedure: Beautibond universal adhesive; Procedure: Tetric N universal bond

• Registration Number: NCT06612021
• Lead Sponsor: Cairo University

Brief Summary

The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.

Detailed Description

The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.

The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.

Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.

Study Timeline

• Study Start: 2023-07-14
• Study First Submitted: 2023-08-25
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-21
• Last Update Submitted: 2024-09-21
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Primary Completion: 2024-10-14
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEMA free universal adhesive group	Beautibond universal adhesive	-
HEMA containing universal adhesive group	Tetric N universal bond	-

Primary Outcome Measures

Name	Time	Method
marginal staining of restoration	baseline ,6 months & 12 months	marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin

Secondary Outcome Measures

Name	Time	Method
caries recurrence	baseline ,6 months ,12 months	caries recurrence using USPHS criteria Alpha: no recurrent caries Charlie: Caries recurrence
marginal adaptation of restoration	baseline ,6 months and 12 months	marginal adaptation using USPHS criteria ALPHA: Marginal continuity BRAVO: slightly detectable marginal discontinuity that does not require replacement CHARLIE: Detectable crevice or ledge at margin that requires replacement

Trial Locations

Locations (1)

Faculty of dentistry Cairo university; 🇪🇬 Cairo, Manyal, Egypt