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Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surface treatment with Bioactive Glass Air Abrasion
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Fissure sealant, Bio-active glass, caries prevention

Eligibility Criteria

17 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Young adult Patients Aged 17-22. Good oral hygiene (plaque index score 0 or 1). Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing). Patients approving to participate in the study. Exclusion Criteria: Patients with known allergic or adverse reaction to the tested materials. Systematic disease that may affect participation. Xerostomic patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion

    Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion

    Arm Description

    giomer based fissure sealnt will be applied without surface treatment

    giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion

    Outcomes

    Primary Outcome Measures

    Loss of sealant's retention
    Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed - Totally lost (TL) No trace of the material was detected on the surface.

    Secondary Outcome Measures

    Secondary Caries
    Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06003452
    Brief Title
    Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
    Official Title
    Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2024 (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

    5. Study Description

    Brief Summary
    Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs. Various preventive strategies for dental caries have been tried and are still being developed. The occlusal pits and fissures of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown to be an evidence-based caries preventive method for protecting the occlusal surfaces against caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to their sealed counterpart. Sealants are effective caries preventive agents as long as they remain bonded to teeth. It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application.A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive.
    Detailed Description
    It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application. A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive3. A new bioactive hybrid material (giomer) that combined the advantages of resin composites with glass ionomer cements has been introduced, it based on pre-reacted glass ionomer (PRG) filler technology in which fluoroaluminosilicate glass particles that have previously reacted with the polyacrylic acid were dispersed in resin. Giomer based pit and fissure sealant using self-etch primer eliminates phosphoric acid etch and rinse, thus conserving the enamel and reducing chair side time. However, retention of self-etch adhesive as compared to conventional sealants is questionable4. A new method for sealant application using air- abrasive technology is less technique sensitive and allows for further cleaning of the grooves prior to sealant placement. The abrasive particles used in air abrasion effectively remove organic plug material from the grooves and allow for deeper penetration of the sealant material into the grooves5. Aim of the study: The aim of study is to evaluate retention rate and caries prevention of giomer based sealant with and without pre-treatment by bioactive glass air abrasion in young adults over one year PICOTS: (P) Patient/Population: Deep retentive fissures ( ICDAS 0,1,2) in second and third molars for 17-22 years old patients. (I) Intervention: Giomer Based Sealant With Prior BioactiveGlass Air Abrasion. (C) Comparator: Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion. (O) Outcome: Prioritization of Outcome Outcome Method of Measurement (with reference) Unit of Measurement ry Outcome: Loss of retention Simonsen's criteria Full retention (FR): The material was fully present on the occlusal surfaces Partially lost (PL): The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed Totally lost (TL): No trace of the material was detected on the surface. ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha: Absence of the caries Charlie: Presence of the caries (T) Time :- T0 :- Baseline T1:- 3 months Study Design: Two parallel arms randomized clinical trial. Study Framework: Superiority framework Hypothesis: The null hypothesis tested in this study is that there will be no difference either in the retention rate or caries prevention of giomer based sealant with and without treatment by bioactive glass air abrasion in young adults Research question: In deep retentive fissures, Will the use of bioactive glass air abrasion particles improve the retention rate and caries prevention of the giomer based sealant? Methodology : In Group 1: the self-etch primer (BeautiSealant Primer, Shofu, Japan) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, gently air blow for about 3 sec and then dry with stronger stream of air until a thin and uniform bonding layer is obtained. The giomer sealant. In Group 2: occlusal surface will be subjected to 5s of bioglass (AquaCare- Velopex International) , then sealant (BeautiSealant Paste, Shofu, Japan) will be applied as aforementioned steps and light-cured for 20 s. In both groups, the surfaces were checked with an explorer to ensure that no voids were present. The occlusion was checked and, if necessary, adjusted.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Fissure sealant, Bio-active glass, caries prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion
    Arm Type
    Active Comparator
    Arm Description
    giomer based fissure sealnt will be applied without surface treatment
    Arm Title
    Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion
    Arm Type
    Experimental
    Arm Description
    giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion
    Intervention Type
    Procedure
    Intervention Name(s)
    surface treatment with Bioactive Glass Air Abrasion
    Intervention Description
    giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion
    Primary Outcome Measure Information:
    Title
    Loss of sealant's retention
    Description
    Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed - Totally lost (TL) No trace of the material was detected on the surface.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Secondary Caries
    Description
    Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Young adult Patients Aged 17-22. Good oral hygiene (plaque index score 0 or 1). Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing). Patients approving to participate in the study. Exclusion Criteria: Patients with known allergic or adverse reaction to the tested materials. Systematic disease that may affect participation. Xerostomic patients.

    12. IPD Sharing Statement

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