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Silver Diamine Fluoride in Molar-Incisor Hypomineralisation

NCT ID: NCT06165042

Last Updated: 2023-12-11

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-05-31

Brief Summary

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The objective of this study is to assess the efficacy of silver diamine fluoride application in molars affected by molar-incisor hypomineralization. Additionally, the study aims to evaluate the effectiveness of the combined application of silver diamine fluoride, commonly used for dentin hypersensitivity, with a glass hybrid restorative system. The goal is to mitigate sensitivity and improve chewing functions in teeth affected by molar-incisor hypomineralization.

Detailed Description

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In a research study focusing on 120 children aged 8-13 with molar incisor hypomineralization (MIH), a comprehensive examination of 240 teeth will be conducted. Study will employ selective caries removal to eliminate decay and subsequently apply restorations. The two intervention groups are delineated as follows:

Group 1: Glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Group 2 : Restoration involving fluoride varnish (SDI Riva Star) + glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Conditions

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Molar-Incisor Hypomineralisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glass hybrid restorative system

(Equia Forte, GC Europe, Leuven, Belgium)

Group Type EXPERIMENTAL

glass hybrid restorative system

Intervention Type OTHER

In the teeth where the indication is identified, selective caries removal will be performed to eliminate the decayed tooth tissue. Subsequently, for each patient in the study apply glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Fluoride varnish + Glass hybrid restorative

Fluoride varnish (SDI Riva Star)+ Glass hybrid restorative (Equia Forte, GC Europe, Leuven, Belgium)

Group Type EXPERIMENTAL

Fluoride varnish + Glass hybrid restorative system

Intervention Type OTHER

In the teeth where the indication is identified, selective caries removal will be performed to eliminate the decayed tooth tissue. Subsequently, for each patient in the study apply Fluoride varnish (SDI Riva Star)+ Glass hybrid restorative (Equia Forte, GC Europe, Leuven, Belgium)

Interventions

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glass hybrid restorative system

In the teeth where the indication is identified, selective caries removal will be performed to eliminate the decayed tooth tissue. Subsequently, for each patient in the study apply glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Intervention Type OTHER

Fluoride varnish + Glass hybrid restorative system

In the teeth where the indication is identified, selective caries removal will be performed to eliminate the decayed tooth tissue. Subsequently, for each patient in the study apply Fluoride varnish (SDI Riva Star)+ Glass hybrid restorative (Equia Forte, GC Europe, Leuven, Belgium)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged between 8 and 13 who are cooperative, having at least 2 teeth with a BAKH-TII score of 4a or 4b.
* Complete occlusion of teeth with MIH.
* Presence of signs of pulpal pathology with symptoms in the teeth included in the study during the pre-treatment clinical examination (absence of spontaneous and prolonged pain, no percussion and palpation sensitivity, no swelling or fistula in soft tissue, presence of periapical radiolucency in radiographs, and absence of internal or external resorption).
* Additionally, no parafunctional habits (e.g., bruxism) and no malocclusion (posterior crossbite).
* Good general health condition, without systemic illnesses.
* Absence of silver allergy.

Exclusion Criteria

* Non-cooperative individuals.
* Having MIH severity outside the specified scoring.
* Presence of systemic diseases.
* Lack of complete occlusion in the molars.
* Presence of parafunctional habits.
* Presence of pulpal pathology.
* Individuals with a silver allergy.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Betül Sen Yavuz, DDS

Role: CONTACT

Phone: +905399887646

Email: [email protected]

Other Identifiers

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MarmaraPedo

Identifier Type: -

Identifier Source: org_study_id