Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint by Using Fibre-reinforced Composite
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 7, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 10, 2017
February 1, 2017
11.5 years
January 7, 2015
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Study Arms (1)
Fibre-reinforced composite
EXPERIMENTALFibreglass 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment
You may not qualify if:
- insufficient interocclusal distance
- poor oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Ege University
Izmir, 35100, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 18540392BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ovul Kumbuloglu, Assoc Prof
Ege University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 7, 2015
First Posted
January 22, 2015
Study Start
June 1, 2003
Primary Completion
December 1, 2014
Study Completion
December 1, 2018
Last Updated
February 10, 2017
Record last verified: 2017-02