Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar.

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization
• Interventions: Other: Silver Diamine Fluoride 38%; Other: fluoride varnish

• Registration Number: NCT05931822
• Lead Sponsor: Mansoura University

Brief Summary

A randomized clinical trial to compare silver modified glass ionomer restorations to non silver glass ionomer restorations in hypo-mineralized first permanent molars in children and to measure the amount of wear of restoration in both groups along with detecting changes in hypersensitivity in hypomineralized molars in both groups after one year follow up.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-10-30
• Study Completion: 2022-12-01
• Study First Submitted: 2023-06-22
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Bilateral first permanent molars affected with molar incisor hypomineralization and with the same ICDAS II score.
• Both chosen molars should be of the same degree of MIH severity.

Exclusion Criteria

• signs and symptoms of irreversible pulpitis or pulp necrosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver Diamine fluoride modified glass ionomer restoration	Silver Diamine Fluoride 38%	-
fluoride varnish and glass ionomer restoration	fluoride varnish	-

Primary Outcome Measures

Name	Time	Method
Measuring surface wear using CAD-CAM software program	after 1 year	impressions were taken after treatment and after one year the two impressions were scanned. The scans were superimposed to compare the surface change. T o standardize the measurements specific selected points on the occlusal surface was used.
Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria	1 year	ART criterion was used to evaluate the restorations done after treatment then once again after one year.

Secondary Outcome Measures

Name	Time	Method
Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)	after 1 year	The molars that were selected for treatment were tested for hypersensitivity. The air was delivered from a standard dental unit air syringe for 1 second at a distance of 1 cm and perpendicular to the occlusal surface of the tooth, before treatment ,after 1 week, 6 months and 12 months.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakaleya, Egypt