Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents in Teeth With MIH

NCT05542667 | Not Yet Recruiting Phase 3

• 1 other identifier: 8484
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (2)

• Absence of pain to the evaporative stimulus

  will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome

  1 month

• Absence of pain to the evaporative stimulus

  will be measured using schiff scale from 0 to 3 , 0 being the better outcome

  1 month

Secondary Outcomes (2)

• Absence of pain to thermal stimulus

  1 month

• Evaluation of oral health-related quality of life (OHRQoL)

  1 month

Study Arms (2)

Giomer varnish

ACTIVE COMPARATOR

PRG coat barrier by SHOFU is varnish based on a new technology named Giomer by incorporating pre-reacted glass ionomer particles, so varnish contains GI particles embedded in a resin matrix, it should be applied once per year since it is the only varnish in the market that is light cured so it is more durable than others.

Combination Product: Giomer varnish

Fluoroide varnish

ACTIVE COMPARATOR

Bifluorid 10 by VOCO is a varnish containing 5% sodium fluoride and 5 % calcium fluoride, it should be applied once each 6 months by a professional dentist and it tends to decrease the hypersensitivity of the teeth as well as decrease the risk of caries.

Combination Product: Fluoride varnish

Interventions

Giomer varnish COMBINATION_PRODUCT

* 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.

Giomer varnish

Fluoride varnish COMBINATION_PRODUCT

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.

Fluoroide varnish

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children :
• 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)
• Systemically healthy.
• Cooperative patients who will comply with follow-up visits.
• Teeth:
• At least one first molar or one incisor erupted in the oral cavity exhibiting molar incisor hypomineralization.
• Teeth representing molar incisor hypomineralization are sensitive.

You may not qualify if:

• Children:
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• Undergoing desensitizing treatments in the last 3 months
• Occlusal problems such as bruxism.
• Cognition problems.
• Who used any type of analgesics before treatment.
• Undergoing orthodontic treatment.
• Teeth:
• Enamel defects as enamel hypoplasia, amelogenesis imperfecta, and dental fluorosis.
• Carious teeth.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: September 15, 2022
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: once the study have been completed