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

Molar Incisor Hypomineralization Clinical Trial

Official title:

Quantitative Evaluation of Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar In A Group Of Children"-A Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931822
• Other study ID #: A05031219
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 1, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Molar Incisor Hypomineralization

Intervention

Other:
• Silver Diamine Fluoride 38%
silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar
• fluoride varnish
fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakaleya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring surface wear using CAD-CAM software program	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.	after 1 year
Primary	Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria	ART criterion was used to evaluate the restorations done after treatment then once again after one year.	1 year
Secondary	Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)	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.	after 1 year