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NCT Number: NCT06165042

Silver Diamine Fluoride in Molar-Incisor Hypomineralisation

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.

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Key information

Conditions

Molar-Incisor Hypomineralisation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34854, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glass hybrid restorative system

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 system

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)

Primary outcomes

  1. United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria

    Time frame: 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).

  2. The Schiff Cold Air Sensitivity Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Silver Diamine Fluoride Application in Molar-Incisor Hypomineralisation-Affected Molars

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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