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

Retention Rate of Flowable Composite in Demenerlized Pits and Fissure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03264105
• Other study ID #: CEBC-CU-2017-07-31
• Status: Not yet recruiting
• Phase: N/A
• First received: July 30, 2017
• Last updated: August 23, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retention Rate of Flowable Composite in Demenerlized Pits and Fissure

Intervention

Other:
• Hydroxyapatite Nanofiber reinforced flowable composite
retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite
• conventional resin-based flowable composite
retention rate evaluation of conventional resin-based flowable composite

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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