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

NCT ID: NCT05931822

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Silver Diamine fluoride modified glass ionomer restoration

Group Type ACTIVE_COMPARATOR

Silver Diamine Fluoride 38%

Intervention Type OTHER

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

fluoride varnish and glass ionomer restoration

Group Type ACTIVE_COMPARATOR

fluoride varnish

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

fluoride varnish

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Aya Ehab

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abeer Abd Elatiif, professor

Role: STUDY_DIRECTOR

Mansoura University, Mansoura, Egypt

Locations

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Mansoura University

Al Mansurah, Dakaleya, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39367399 (View on PubMed)

Other Identifiers

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A05031219

Identifier Type: -

Identifier Source: org_study_id

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