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

July 3, 2023 updated by: Aya Ehab, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakaleya
      • Mansoura, Dakaleya, Egypt, 35511
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silver Diamine fluoride modified glass ionomer restoration
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
Active Comparator: fluoride varnish and glass ionomer restoration
Other: fluoride varnish
fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring surface wear using CAD-CAM software program
Time Frame: 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.
after 1 year
Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria
Time Frame: 1 year
ART criterion was used to evaluate the restorations done after treatment then once again after one year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)
Time Frame: 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.
after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Abeer Abd Elatiif, professor, Mansoura University, Mansoura, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A05031219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

my research is still under publishing and i am planning to get published within 1-2 months. Data in my research can be shared afterwards.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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