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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional resin-based flowable composite

Group Type ACTIVE_COMPARATOR

Conventional resin-based flowable composite

Intervention Type OTHER

assessment of marginal integrity of Conventional resin-based flowable composite

Hydroxyapatite Nanofiber reinforced flowable composite

Intervention Type OTHER

assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite

Hydroxyapatite Nanofiber reinforced flowable composite

Group Type OTHER

Conventional resin-based flowable composite

Intervention Type OTHER

assessment of marginal integrity of Conventional resin-based flowable composite

Hydroxyapatite Nanofiber reinforced flowable composite

Intervention Type OTHER

assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite

Interventions

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Conventional resin-based flowable composite

assessment of marginal integrity of Conventional resin-based flowable composite

Intervention Type OTHER

Hydroxyapatite Nanofiber reinforced flowable composite

assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite

Intervention Type OTHER

Eligibility Criteria

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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