Clinical trial

Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents Among a Group of Children With Molar Incisor Hypomineralization : A Controlled Clinical Trial

Name

8484

Description

this clinical trial's aim is to compare two desensitizing agents available in the market to prove which one is more efficient in children with molar incisor hypomineralization complaining from hypersensitivity

Trial arms

Trial start

2025-02-01

Estimated PCD

2025-05-01

Trial end

2026-08-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Giomer varnish

* After dryness and isolation are accomplished, Giomer varnish ( PRG coat barrier, by Shofu) will be applied once at the first treatment visit, one drop of PRG Coat Barrier ACTIVE will be added to the container provided in the package containing PRG Coat Barrier BASE the materials will be mixed together with a disposable tip provided by the kit a thin layer is to be applied and left untouched for 3 seconds according to manufacturer instructions and finally varnish is to be light-cured.

Arms:

Giomer varnish

Fluoride varnish

After dryness and isolation are accomplished, fluoride varnish (Biflourid 10, by Voco ) single-use type, the foil in the single-use Bifluorid 10 will be pierced using Micro-Tim brush, then a thin layer of the varnish is to be applied using a micro brush for four sessions at a frequency of one session each week, the varnish will be left undisturbed for 10-20 seconds then air-dried according to manufacturer instructions.

Arms:

Fluoroide varnish

Size

Primary endpoint

Absence of pain to the evaporative stimulus

1 month

Absence of pain to the evaporative stimulus

1 month

Eligibility criteria

Inclusion Criteria: * Children : 1. Patients aged between 8 and 10 years old with MIH affected teeth according to European Academy of Pediatric Dentistry diagnostic criteria (Lygidakis et al., 2022) 2. Systemically healthy. 3. Cooperative patients who will comply with follow-up visits. * Teeth: 1. At least one first molar or one incisor erupted in the oral cavity exhibiting molar incisor hypomineralization. 2. Teeth representing molar incisor hypomineralization are sensitive. - Exclusion Criteria: * • Children:  1. Undergoing desensitizing treatments in the last 3 months 2. Occlusal problems such as bruxism. 3. Cognition problems. 4. Who used any type of analgesics before treatment. 5. Undergoing orthodontic treatment. * Teeth: 1. Enamel defects as enamel hypoplasia, amelogenesis imperfecta, and dental fluorosis. 2. Carious teeth.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

Updated at

2023-09-01

1 organization

2 products

1 indication

Organization

Cairo University

Product

Giomer varnish

Indication

Molar-Incisor Hypomineralization

Product

Fluoride varnish