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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02343796
Recruitment Status : Unknown
Verified February 2017 by Ovul Kumbuloglu, Ege University.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Ovul Kumbuloglu, Ege University

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
Tooth Loss Tooth Mobility Other: Fibreglass reinforced composite restoration-everStick Device: everStick Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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 : June 2003
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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

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. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02343796

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Ege University
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
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Principal Investigator: Ovul Kumbuloglu, Assoc Prof Ege University

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Responsible Party: Ovul Kumbuloglu, Associate Professor, Ege University Identifier: NCT02343796     History of Changes
Other Study ID Numbers: 14-9.1/4
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD would be considered for sharing with other reseachers during manuscript preparation.

Keywords provided by Ovul Kumbuloglu, Ege University:
Fiberglass reinforced resins

Additional relevant MeSH terms:
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Tooth Loss
Tooth Mobility
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases