Silver Diamine Fluoride in Molar-Incisor Hypomineralisation

Not Applicable

Not yet recruiting

• Conditions: Molar-Incisor Hypomineralisation
• Interventions: Other: glass hybrid restorative system; Other: Fluoride varnish + Glass hybrid restorative system

• Registration Number: NCT06165042
• Lead Sponsor: Marmara University

Brief Summary

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

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)

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glass hybrid restorative system	glass hybrid restorative system	(Equia Forte, GC Europe, Leuven, Belgium)
Fluoride varnish + Glass hybrid restorative	Fluoride varnish + Glass hybrid restorative system	Fluoride varnish (SDI Riva Star)+ Glass hybrid restorative (Equia Forte, GC Europe, Leuven, Belgium)

Primary Outcome Measures

Name	Time	Method
The Schiff Cold Air Sensitivity Score	1.5-2 year	The Schiff Cold Air Sensitivity Score is a test conducted in dental units. Cold air from a spray is applied to the surface of the tooth's dentin, 2-3 mm away, and at a 90-degree angle, with continuous pressure of 45-60 PSI for 2-3 seconds, following the isolation of neighboring teeth. The temperature should be around 20 degrees Celsius. The patient's pain level is then scored by the dentist using a scale.; * Score 0: No response to the stimulus.; * Score 1: Responds to the stimulus but does not request it to be stopped.; * Score 2: Responds to the stimulus, requests it to be stopped, or makes movements to avoid it.; * Score 3: Responds to the stimulus, finds it painful, and requests it to be stopped.
United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria	1.5 -2 year	Restorations were evaluated to determine success according to modified United States Public Health Service (USPHS) criteria for marginal adaptation, marginal discolouration, secondary caries, anatomical form, retention, postoperative sensitivity and colour matching. Restorations with an "Alpha (A)" score were considered successful, those with a "Bravo (B)" score were considered acceptable, and those with a "Charlie (C)" score were considered unsuccessful. The scoring of the restorations was decided by agreement of both dentists (Ryge G. et al., 1980).