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Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint by Using Fibre-reinforced Composite

Sponsor
Ege University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02343796
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
186
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether fibre-reinforced composite resin restorations are effective for single tooth replacement, elimination of tooth mobility following periodontal treatment and as an orthodontic retainer.

Condition or Disease Intervention/Treatment Phase
  • Other: Fibreglass reinforced composite restoration-everStick
  • Device: everStick
 N/A

Detailed Description

Adhesive dentistry is based on preventive dental approach. In presence of such advanced and minimally invasive techniques, destructive treatment methods should not be preferred for clinical situations, such as missing single tooth cases, tooth mobility following periodontal treatment and prevention of relapse after orthodontic treatments. Glass fibre is a reinforcement material, and increases the flexibility of the material together which it has been used. Fibre-reinforced applications by using direct or indirect techniques. This material and method is easily applicable, biocompatible, repairable and economical on a high extent.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint Applications by Using Fibre-reinforced Composite.
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fibre-reinforced composite

Fibreglass reinforced composite restoration-everStick as a medical device intervention will be applied on each subject by using either direct or indirect method. everStick (GC, Belgium) will be used as a fibre reinforcement material.

Other: Fibreglass reinforced composite restoration-everStick
For those subjects with space availability on interocclusal distance, composite resin restorations with fibreglass reinforcement will be applied without any tooth preparation by using adhesive techniques.

Device: everStick
GC, Belgium

Outcome Measures

Primary Outcome Measures

  1. Number of participants with clinical survival of the applied restoration, splint or retainer, as indicated by observations for any fractures on composite. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment
Exclusion Criteria:

  • insufficient interocclusal distance

  • poor oral hygiene

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Izmir Turkey 35100

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Ovul Kumbuloglu, Assoc Prof, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ovul Kumbuloglu, Associate Professor, Ege University
ClinicalTrials.gov Identifier:
NCT02343796
Other Study ID Numbers:
  • 14-9.1/4
First Posted:
Jan 22, 2015
Last Update Posted:
Feb 10, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Ovul Kumbuloglu, Associate Professor, Ege University
Fiberglass reinforced resins
Additional relevant MeSH terms:
Tooth Loss
Tooth Mobility

Study Results

No Results Posted as of Feb 10, 2017