Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
Primary Purpose
Demineralization, Tooth, Demineralization, Fissure, Non-Cavitated Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fissure sealing
Sponsored by
About this trial
This is an interventional treatment trial for Demineralization, Tooth
Eligibility Criteria
Inclusion Criteria:
- Patients with good oral hygiene
- Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
Exclusion Criteria:
- Medical Problems or Pregnancy
- Lack of patient's approval and compliance
- Presence of abnormal oral, medical, or mental condition
- Known allergy of resin-based materials
- Previous placements of sealants or restorations
- Bruxism or mal-occlusion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bioactive resin (Giomer)
Conventional resin
Arm Description
This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures
Outcomes
Primary Outcome Measures
Retention
The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
Secondary Outcome Measures
Marginal integrity
The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
Caries progression
The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052802
Brief Title
Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
Official Title
The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2019 (Anticipated)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
Detailed Description
Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.
The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Demineralization, Tooth, Demineralization, Fissure, Non-Cavitated Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bioactive resin (Giomer)
Arm Type
Experimental
Arm Description
This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
Arm Title
Conventional resin
Arm Type
Experimental
Arm Description
This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures
Intervention Type
Other
Intervention Name(s)
Fissure sealing
Intervention Description
The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
Primary Outcome Measure Information:
Title
Retention
Description
The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Marginal integrity
Description
The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
Time Frame
18 months
Title
Caries progression
Description
The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with good oral hygiene
Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
Exclusion Criteria:
Medical Problems or Pregnancy
Lack of patient's approval and compliance
Presence of abnormal oral, medical, or mental condition
Known allergy of resin-based materials
Previous placements of sealants or restorations
Bruxism or mal-occlusion
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will be assessed collectively for ll participants and statistically analyzed and published with the results. Other data can be provided apon request if ethically approved.
Learn more about this trial
Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
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