Retention Rate of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional

Retention Rate 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

Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth .Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants

Study Overview

• Status: Unknown
• Conditions: Retention Rate of Flowable Composite in Demenerlized Pits and Fissure
• Intervention / Treatment: Other: Hydroxyapatite Nanofiber reinforced flowable composite; Other: conventional resin-based flowable composite

Detailed Description

Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures makes them an ideal site for retention of bacteria and food remnants, rendering the performance of proper hygiene difficult or even impossible .

Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants . However, the clinical longevity of flowable composite as fissure sealants is directly related to their retention, where the percentage of rate of retention differ on a 12-month follow-up examination were the partial loss rate of flowable composite material ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate isolation, conditioning of enamel, application techniques, particular material characteristics like viscosity, surface tension, adequate adhesion and penetration of the material into the previously etched system of fissures.

In order to overcome the shortcomings of traditional dental composites, nanofibers or nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are calcium phosphates fillers that allow the release of mineral from dental resin composite. Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and thin structure, and create a lot of bonding points in the interface with polymeric matrix. When the composites suffer from huge pressure this allow tremendous stress transfer from weak polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties of resin composite. So this study will examine the effect of adding HAP nanofibers on the clinical performances and retention rate of flowable resin composite.

• Study Type: Interventional
• Enrollment (Anticipated): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older 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. Patient with at least 2 non-cavitated initial occlusal carious lesion in 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 cavitated carious lesion. Previously placed sealants or restorations. Bruxism or malocclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovaPro™ Flow; NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA	Other: Hydroxyapatite Nanofiber reinforced flowable composite; retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite; Other: conventional resin-based flowable composite; retention rate evaluation of conventional resin-based flowable composite
Active Comparator: Conventional resin-based flowable composite; Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA	Other: Hydroxyapatite Nanofiber reinforced flowable composite; retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite; Other: conventional resin-based flowable composite; retention rate evaluation of conventional resin-based flowable composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate evaluation of both restoration	restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. Totally lost (TL): no trace of materials was detected on the surface.	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2017-07-31

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.: Yes