Molar Incisor Hypomineralization Clinical Trial
— MIH_GICOfficial title:
Evaluation of Efficiency, Acceptance and the Durability of Glass-Ionomer Sealing Technique on Hypersensitive MIH (Molar Incisor Hypomineralisation) Teeth With and Without Enamel Breakdown - a Cohort Study
NCT number | NCT05945381 |
Other study ID # | BB 047/23 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | December 2024 |
This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 & 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: - Self-reported hypersensitive MIH molar (MIH-TNI 3 & 4a/b/c). - Children & adolescents without systematic health diseases. - No sealing therapy or application of desensitizing agent on the MIH-teeth within 1 month before participation in the study. - Agreement to voluntary participation in the study. Exclusion Criteria: - Patients with acute pain/ patients with signs or symptoms to be treated. - Patients with systemic disease that require special attention during their dental treatment. - Parents / children who refused to participate in the study. - MIH teeth with signs of irreversible pulpitis. - Allergy against any ingredients of the material. |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Preventive and Pediatric Dentistry, University of Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypersensitivity (mid-term) | Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0) | 3 months | |
Primary | Hypersensitivity (short-term) | Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) after 15 minutes according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0) | 15 minutes | |
Secondary | child acceptance of procedure | - Assessment of acceptance of the child toward the procedure using Likert Scale (scale: 1-5) | 15 minutes | |
Secondary | hypersensitivity: assessment of the child | Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) regarding self-report of the patient using Wong- Baker Faces Rating Scale. (0-10; 0=no hurt; 10=hurts worst) | 15 minutes | |
Secondary | durability | Evaluation of durability of the sealant material on the MIH-teeth using modified USPHS assessment's criteria (in 3 months' recall).
Scale Alpha: No loss of sealing material Bravo: Partial loss of sealing material Charlie: Loss of restorative material |
3 months |
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