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

Not Applicable

• Conditions: Tooth Loss; Tooth Mobility
• Interventions: Other: Fibreglass reinforced composite restoration-everStick; Device: everStick

• Registration Number: NCT02343796
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-06
• Primary Completion: 2014-12
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibre-reinforced composite	everStick	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.
Fibre-reinforced composite	Fibreglass reinforced composite restoration-everStick	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Turkey