Silver Diamine Fluoride in Molar-Incisor Hypomineralisation

Marmara University

Status: Not yet enrolling

Conditions: Molar-Incisor Hypomineralisation

Treatments: Other: Fluoride varnish + Glass hybrid restorative system; Other: glass hybrid restorative system

Study type: Interventional

Funder types: Other

Identifiers

NCT06165042

MarmaraPedo

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 120 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Glass hybrid restorative system

Experimental group

Description:

(Equia Forte, GC Europe, Leuven, Belgium)

Treatment:

Other: glass hybrid restorative system

Fluoride varnish + Glass hybrid restorative

Experimental group

Description:

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

Treatment:

Other: Fluoride varnish + Glass hybrid restorative system