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

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.

Study Overview

• Status: Unknown
• Conditions: Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite
• Intervention / Treatment: Other: Conventional resin-based flowable composite; Other: Hydroxyapatite Nanofiber reinforced flowable composite

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

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional resin-based flowable composite	Other: Conventional resin-based flowable composite; assessment of marginal integrity of Conventional resin-based flowable composite; Other: Hydroxyapatite Nanofiber reinforced flowable composite; assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
Other: Hydroxyapatite Nanofiber reinforced flowable composite	Other: Conventional resin-based flowable composite; assessment of marginal integrity of Conventional resin-based flowable composite; Other: Hydroxyapatite Nanofiber reinforced flowable composite; assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders
• Other Study ID Numbers: CEBC-CU-2017-7-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No