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Completed

NCT Number: NCT05931822

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

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.

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Key information

Conditions

Molar Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakaleya, 35511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silver Diamine Fluoride 38%

Other

silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar

fluoride varnish

Other

fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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