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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-10
SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

At least one first molar or one incisor erupted in the oral cavity exhibiting molar incisor hypomineralization.

Disqualifiers

Undergoing desensitizing treatments in the last 3 months

Occlusal problems such as bruxism.

Cognition problems.

Who used any type of analgesics before treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Giomer varnishActive comparator 1 intervention
Group B: Fluoroide varnishActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 month
2

Absence of pain to the evaporative stimulus

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

Time frame
1 month

Secondary outcomes

1

Absence of pain to thermal stimulus

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

Time frame
1 month
2

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

measured using the Arabic child perception questionnaire from age 8-10 years old , contains 25 questions and each answer is rating from 0 to 4 , 0 being the better outcome

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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