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CompletedNCT06165042Updated Apr 6, 2026

Silver Diamine Fluoride in Molar-Incisor Hypomineralisation

An interventional study of glass hybrid restorative system and Fluoride varnish + Glass hybrid restorative system in Molar-Incisor Hypomineralisation, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Molar-Incisor Hypomineralisation
03

In context

Molar Hypomineralization

121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.

This study's enrollment of 34 is below the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Glass hybrid restorative system

    (Equia Forte, GC Europe, Leuven, Belgium)

    Other: glass hybrid restorative system

  • Experimental
    Fluoride varnish + Glass hybrid restorative

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

    Other: Fluoride varnish + Glass hybrid restorative system

Interventions

  • Otherglass 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)

  • OtherFluoride 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)

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 1.5 -2 year

  2. The Schiff Cold Air Sensitivity Score

    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.

    Time frame: 1.5-2 year

07

Study locations

1 site
  • Marmara University
    Istanbul, 34854, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06165042
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Apr 1, 2024
Primary completion
Dec 26, 2024
Completion
Jan 30, 2025
Last update
Apr 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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