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

Primary Purpose

Tooth Loss, Tooth Mobility

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Fibreglass reinforced composite restoration-everStick

everStick

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Fiberglass reinforced resins

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ege University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibre-reinforced composite

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02343796

First Posted

January 7, 2015

Last Updated

February 9, 2017

Sponsor

Ege University

1. Study Identification

Unique Protocol Identification Number

NCT02343796

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2003 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss, Tooth Mobility

Keywords

Fiberglass reinforced resins

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibre-reinforced composite

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Fibreglass reinforced composite restoration-everStick

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

everStick

Intervention Description

GC, Belgium

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ovul Kumbuloglu, Assoc Prof

Organizational Affiliation

Ege University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ege University

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

IPD would be considered for sharing with other reseachers during manuscript preparation.

Citations:

PubMed Identifier

18540392

Citation

Kumbuloglu O, Ozcan M, User A. Fracture strength of direct surface-retained fixed partial dentures: effect of fiber reinforcement versus the use of particulate filler composites only. Dent Mater J. 2008 Mar;27(2):195-202. doi: 10.4012/dmj.27.195.

Results Reference

background

Learn more about this trial

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

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