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

NCT05931822 | Completed

• 1 other identifier: A05031219
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Keywords

MIH, silver diamine fluoride, children, glass ionomer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)

  after 1 year

Study Arms (2)

Silver Diamine fluoride modified glass ionomer restoration

ACTIVE COMPARATOR

Other: Silver Diamine Fluoride 38%

fluoride varnish and glass ionomer restoration

ACTIVE COMPARATOR

Other: fluoride varnish

Interventions

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

Silver Diamine fluoride modified glass ionomer restoration

fluoride varnish OTHER

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

fluoride varnish and glass ionomer restoration

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• signs and symptoms of irreversible pulpitis or pulp necrosis.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakaleya, 35511, Egypt

Location

Related Publications (1)

• Saad AE, Alhosainy AY, Abdellatif AM. "Evaluation of Silver Diamine Fluoride Modified Atraumatic Restorative Treatment (SMART) on hypomineralized first permanent molar"- a randomized controlled clinical study. BMC Oral Health. 2024 Oct 4;24(1):1182. doi: 10.1186/s12903-024-04860-z.

  PMID: 39367399 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

Study Officials

• Abeer Abd Elatiif, professor

  Mansoura University, Mansoura, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 5, 2023
• Study Start: September 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 1, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)