Molar Incisor Hypomineralization Clinical Trial
Official title:
MANAGEMENT OF HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN (RANDOMIZED CLINICAL TRIAL)
Verified date | September 2023 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. A sample of children having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH). All selected 45 first permanent molars will be randomly equally allocated into three groups. DH will be evaluated after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10).
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility | Inclusion Criteria: - 6-10-year-old children (15). - At least one tooth with MIH and DH reported in the occlusal region with sensitivity equal to or greater than 4 on the Visual analogue Scale (VAS). - Good overall health (ASA I). Exclusion Criteria: - First permanent molars with active carious lesions or defective restorations - Sufficient dentin loss that requires restorative therapy. - Any clinical signs of failure (abscess, fistula). - Patients with systemic diseases. - Having undergone any professional desensitizing treatment in the previous 6 months. - Having used a desensitizing paste in the previous 3 months. - Use of anti-inflammatory drugs or analgesics at the time of recruitment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Alexandria University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dentin Hypersensitivity | it will be measures usinf a Faces pain scale | Day0, 1 week, 1 month, 3 months and 6 months | |
Secondary | Oral health related Quality of life (OHRQoL) | OHRQoL will be assessed for all children through the validated Arabic version of the Child Perceptions Questionnaire (CPQ8-10)which will be administered at the beginning and the end of the treatment. The questionnaire evaluates the severity of oral symptoms, functional limitations as well as emotional and social well-being. The questions are measured using a 5-point Likert scale as follows: never = 0, once or twice = 1, sometimes = 2, often = 3, and Every day or almost every day = 4. Hence, total scores range from 0 to100, and higher scores indicate poorer OHRQoL. | Day 0 |
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