Endodontically Treated TeethNCT06346769
Composite Restorations Performed by Placing Polyethylene Fiber
A study testing Polyethylene Fiber in people with Endodontically Treated Teeth, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Polyethylene Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Apr 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- endodontically treated premolar and molar teeth
- teeth in contact with the opposing tooth and subjected to normal occlusal forces
- attend follow-up appointments
Who cannot join
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
- systemically unhealthy
- pregnant and lactating women
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
Konya
Selcuk University, Faculty of Dentistry
Konya
About this study
Official title: Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth
This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p<0.05).
- Conditions
- Endodontically Treated Teeth
- Being tested
- Polyethylene Fiber
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene FiberOther
In the restoration of the endodontically treated posterior teeth, polyethylene fiber was placed in different directions ('O' shape, mesiodistal I shape, buccolingual I shape) according to the amount of remaining tooth tissue and cavity preparation.
| Study group | Role | What they receive |
|---|---|---|
| 'O' shape polyethylene fiber | Experimental | Not described Receives: Other: Polyethylene Fiber |
| mesiodistal I shape polyethylene fiber | Experimental | Not described Receives: Other: Polyethylene Fiber |
| buccolingual I shape polyethylene fiber | Experimental | Not described Receives: Other: Polyethylene Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
No loss of restorative material
Measured: Seventh day, sixth month, twelfth month
Color match
The restoration matches the adjacent tooth structure in color and translucency
Measured: Seventh day, sixth month, twelfth month
Marginal Discoloration
There is no discoloration anywhere on the margin between the restoration and the tooth structure
Measured: Seventh day, sixth month, twelfth month
Marginal adaptation
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Measured: Seventh day, sixth month, twelfth month
Secondary caries
No evidence of secondary caries
Measured: Seventh day, sixth month, twelfth month
Surface texture
The surface of the restoration does not have any defects
Measured: Seventh day, sixth month, twelfth month
Anatomical form
The restoration is continuous with the existing anatomic form
Measured: Seventh day, sixth month, twelfth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gurses, Selcuk University
- Investigators
- MERVE GÜRSES, Principal investigator, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346769
- Sponsor's protocol ID
- SelcukB
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth
- ClinicalTrials.gov ID
- NCT06346769
- Acronym / sponsor ID
- SelcukB
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- 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.
This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 'O' shape polyethylene fiber | Experimental | Other: Polyethylene Fiber |
| mesiodistal I shape polyethylene fiber | Experimental | Other: Polyethylene Fiber |
| buccolingual I shape polyethylene fiber | Experimental | Other: Polyethylene Fiber |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- endodontically treated premolar and molar teeth
- teeth in contact with the opposing tooth and subjected to normal occlusal forces
Key exclusion criteria (7 listed)
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
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 |
|---|---|---|
| Polyethylene FiberIn the restoration of the endodontically treated posterior teeth, polyethylene fiber was placed in different directions ('O' shape, mesiodistal I shape, buccolingual I shape) according to the amount of remaining tooth tissue and cavity preparation. | Other | 'O' shape polyethylene fiber, buccolingual I shape polyethylene fiber, mesiodistal I shape polyethylene fiber |
Primary outcome
Retention
Time frame: Seventh day, sixth month, twelfth month
No loss of restorative material
Color match
Time frame: Seventh day, sixth month, twelfth month
The restoration matches the adjacent tooth structure in color and translucency
Marginal Discoloration
Time frame: Seventh day, sixth month, twelfth month
There is no discoloration anywhere on the margin between the restoration and the tooth structure
Marginal adaptation
Time frame: Seventh day, sixth month, twelfth month
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Secondary caries
Time frame: Seventh day, sixth month, twelfth month
No evidence of secondary caries
Surface texture
Time frame: Seventh day, sixth month, twelfth month
The surface of the restoration does not have any defects
Anatomical form
Time frame: Seventh day, sixth month, twelfth month
The restoration is continuous with the existing anatomic form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
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Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
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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.
MERVE GÜRSES principal investigator
Selcuk University, Faculty of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene Fiber in people with Endodontically Treated Teeth, run by Selcuk University at 2 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention (time frame: Seventh day, sixth month, twelfth month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.