Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedStudy Start
First participant enrolled
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedAugust 12, 2019
August 1, 2019
1.6 years
August 5, 2019
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
18 months
Secondary Outcomes (2)
Marginal integrity
18 months
Caries progression
18 months
Study Arms (2)
Bioactive resin (Giomer)
EXPERIMENTALThis group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
Conventional resin
EXPERIMENTALThis group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures
Interventions
The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
Eligibility Criteria
You may qualify if:
- Patients with good oral hygiene
- Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 12, 2019
Study Start
August 30, 2019
Primary Completion
March 30, 2021
Study Completion
April 30, 2021
Last Updated
August 12, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
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.