Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
Primary Purpose
Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional resin-based flowable composite
Hydroxyapatite Nanofiber reinforced flowable composite
Sponsored by
About this trial
This is an interventional prevention trial for Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite
Eligibility Criteria
Inclusion Criteria:
- Patients should be over 18 Years old.
- Patient should have good oral hygiene and general health
- With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible
Exclusion Criteria:
- Known allergy to any of the resins used,
- Clinically detectable caries,
- Previously placed sealants or restorations,
- Bruxism or malocclusion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
conventional resin-based flowable composite
Hydroxyapatite Nanofiber reinforced flowable composite
Arm Description
Outcomes
Primary Outcome Measures
marginal integrity of both restorations
restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03242291
Brief Title
Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
Official Title
Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (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
This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.
Detailed Description
A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional resin-based flowable composite
Arm Type
Active Comparator
Arm Title
Hydroxyapatite Nanofiber reinforced flowable composite
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Conventional resin-based flowable composite
Intervention Description
assessment of marginal integrity of Conventional resin-based flowable composite
Intervention Type
Other
Intervention Name(s)
Hydroxyapatite Nanofiber reinforced flowable composite
Intervention Description
assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
Primary Outcome Measure Information:
Title
marginal integrity of both restorations
Description
restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients should be over 18 Years old.
Patient should have good oral hygiene and general health
With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible
Exclusion Criteria:
Known allergy to any of the resins used,
Clinically detectable caries,
Previously placed sealants or restorations,
Bruxism or malocclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
donia mamdouh elshafey, master
Phone
01008820027
Ext
002
Email
doniaelshafey90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed mostafa radwan, PHD
Phone
01005148901
Ext
002
Email
mohamedmostafa23@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
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