Tooth LossNCT02343796
Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint by Using Fibre-reinforced Composite
A study testing Fibreglass reinforced composite restoration-everStick and everStick in people with Tooth Loss and Tooth Mobility, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Loss, Tooth Mobility
- What is being tested?
- Fibreglass reinforced composite restoration-everStick and everStick
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2003to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment
Who cannot join
- insufficient interocclusal distance
- poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint Applications by Using Fibre-reinforced Composite.
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.
Read the 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.
- Conditions
- Tooth Loss, Tooth Mobility
- Being tested
- Fibreglass reinforced composite restoration-everStick, everStick
- Keywords
- Fiberglass reinforced resins
- Medical subject headings
- Tooth Loss, Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibreglass reinforced composite restoration-everStickOther
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.
everStickDevice
GC, Belgium
| Study group | Role | What they receive |
|---|---|---|
| Fibre-reinforced composite | Experimental | 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. Receives: Other: Fibreglass reinforced composite restoration-everStick; Device: everStick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical survival of the applied restoration, splint or retainer, as indicated by observations for any fractures on composite.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJun 2003
- Primary completionDec 2014
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ovul Kumbuloglu, Ege University
- Investigators
- Ovul Kumbuloglu, Assoc Prof, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343796
- Sponsor's protocol ID
- 14-9.1/4
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD would be considered for sharing with other reseachers during manuscript preparation.
Publications
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.
PubMed 18540392
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint Applications by Using Fibre-reinforced Composite.
- ClinicalTrials.gov ID
- NCT02343796
- Acronym / sponsor ID
- 14-9.1/4
- Conditions
- Tooth Loss, Tooth Mobility
- Keywords
- Fiberglass reinforced resins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibre-reinforced composite | Experimental | Other: Fibreglass reinforced composite restoration-everStick, Device: everStickFibreglass 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment
Key exclusion criteria (2 listed)
- insufficient interocclusal distance
- poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibreglass reinforced composite restoration-everStickFor 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. | Other | Fibre-reinforced composite |
| everStickGC, Belgium | Device | Fibre-reinforced composite |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 18540392Kumbuloglu 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.
- Individual participant dataSharing planned: Undecided. IPD would be considered for sharing with other reseachers during manuscript preparation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ovul Kumbuloglu, Assoc Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibreglass reinforced composite restoration-everStick and everStick in people with Tooth Loss and Tooth Mobility, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02343796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.