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

Primary Purpose

Molar Incisor Hypomineralization

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Giomer varnish
Fluoride varnish
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Giomer varnish

    Fluoroide varnish

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    Absence of pain to the evaporative stimulus
    will be measured using schiff scale from 0 to 3 , 0 being the better outcome

    Secondary Outcome Measures

    Absence of pain to thermal stimulus
    will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
    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

    Full Information

    First Posted
    August 17, 2022
    Last Updated
    August 31, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05542667
    Brief Title
    Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents in Teeth With MIH
    Official Title
    Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents Among a Group of Children With Molar Incisor Hypomineralization : A Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2025 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    August 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    Interventions The principal investigator will carry out all treatment procedures, and the patients will be assigned. For both interventions: Informed consent from participating parents. Baseline records photographs and personal data collection . Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of desensitizing agent that will be used then writing the patient name and I.D. on it and will be opened in the first visit of treatment). Diagnostic chart with personal, medical, and dental history will be filled. Evaluation of oral health-related quality of life as a baseline, using the Arabic version of the child perception questionnaire-8-10m indicated for children from age 8 to 10 years old, it consists of 25 questions related to oral symptoms (5 questions), functional limitations ( 5 questions), emotional wellbeing (5 questions) and social wellbeing ( 10 questions), responses are made on an ordinal scale ( 0 = never, 1 = once/twice, 2= sometimes, 3= often, 4= every day/ almost every day). Teeth will be cleaned with prophylaxis paste using a low-speed contra brush then teeth will be inspected using a dental mirror and reflected light of the dental unit and the teeth must be moist during the clinical examination to assess the clinical inclusion criteria according to European Academy of Pediatric Dentistry diagnostic criteria. Preoperative, intraoperative, and Postoperative photographs will be taken. Prior to initiation of the treatment, all included teeth will be evaluated for pain in response to an evaporative stimulus using the triple syringe, the air is directed perpendicular to teeth and held at approximately 2 mm for 3 seconds and children are informed to raise their hands or fingers when any discomfort is felt and then the pain is evaluated using the Wong-Baker faces rating scale and Schiff scale. Teeth also are evaluated to thermal stimulus, using an anesthetic carpule refrigerated at 4c for at least 24 hours and the carpule is to be placed in contact with the tooth for 1 to 5 seconds according to child response and pain is to be evaluated as with evaporative stimulus. Application of rubber dam for isolation. Prior to treatment, teeth received prophylaxis using pumice paste, cleaned using the triple water syringe, and dried. Children will then be allocated into either one of the groups alternatively depending on the desensitizing agent used as follows: Group I (Experimental group) Giomer varnish. Group II (Control group) Fluoride varnish.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molar Incisor Hypomineralization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Giomer varnish
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Fluoroide varnish
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Giomer varnish
    Intervention Description
    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.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Fluoride varnish
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Absence of pain to the evaporative stimulus
    Description
    will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
    Time Frame
    1 month
    Title
    Absence of pain to the evaporative stimulus
    Description
    will be measured using schiff scale from 0 to 3 , 0 being the better outcome
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Absence of pain to thermal stimulus
    Description
    will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
    Time Frame
    1 month
    Title
    Evaluation of oral health-related quality of life (OHRQoL)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. - Exclusion Criteria: • Children: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study protocol ,details about interventions , statistical methods used and results will all be shared with others.
    IPD Sharing Time Frame
    once the study have been completed

    Learn more about this trial

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

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