PeriodontitisNCT07729904
Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
An observational study of Periodontitis and Tooth Mobility, run by Emre Taşlı at 1 site in Turkey (Türkiye).
Trial summary
Periodontal disease may cause loss of supporting tissues and increased tooth mobility, particularly in the anterior region, leading to functional and esthetic problems. Fiber-reinforced periodontal splinting is used to stabilize mobile teeth and improve patient comfort while preserving natural dentition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Tooth Mobility
- What is being tested?
- Intracoronal Fiber-Reinforced Periodontal Splint
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with periodontitis presenting with pathologic mobility of one or more anterior teeth due to periodontal attachment loss who received intracoronal ultra-high molecular weight polyethylene fiber (Ribbond®) periodontal splinting following active periodontal therapy at the Faculty of Dentistry, Selcuk University.
Who may be able to join
- Adults aged 18 years or older. Presence of at least one maxillary or mandibular anterior tooth with pathologic mobility due to periodontal attachment loss requiring intracoronal ultra-high molecular weight polyethylene fiber (Ribbond®) splinting, performed as an adjunct to non-surgical (Phase I) or surgical (Phase II) periodontal therapy, or following completion of periodontal therapy.
- Willingness to attend all scheduled follow-up visits during the study period. Provision of written informed consent.
Who cannot join
- Age younger than 18 years. Pregnancy. Splint placement performed for dentoalveolar trauma rather than periodontal attachment loss.
- History of chemotherapy, radiotherapy, or immunosuppressive therapy. Temporary splinting intended only for provisional periodontal stabilization. Splinting performed using materials other than ultra-high molecular weight polyethylene fiber (Ribbond®), including wire-composite or composite-only splints.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry
Konya, Konya, 42250
About this study
Official title: Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
Periodontal disease may cause loss of supporting tissues and increased tooth mobility, particularly in the anterior region, leading to functional and esthetic problems. Fiber-reinforced periodontal splinting is used to stabilize mobile teeth and improve patient comfort while preserving natural dentition. The aim of this study is to evaluate the 12-month clinical performance of intracoronal ultra-high molecular weight polyethylene fiber-reinforced periodontal splints in periodontally compromised anterior teeth. Periodontal, restorative, radiographic, and patient-reported outcomes will be assessed at baseline and during follow-up visits at 1, 3, 6, and 12 months.
Read the detailed description
Periodontal attachment loss may result in pathologic tooth mobility, compromising function, esthetics, and quality of life. Periodontal splinting is commonly used as an adjunctive treatment to stabilize mobile teeth following periodontal therapy. However, evidence regarding the long-term periodontal and restorative performance of intracoronal fiber-reinforced splints remains limited.
This prospective observational cohort study evaluates the clinical performance of intracoronal periodontal splints fabricated with ultra-high molecular weight polyethylene fiber in periodontally compromised anterior teeth. Patients received comprehensive periodontal therapy before splint placement. Clinical periodontal parameters, including probing depth, clinical attachment level, plaque index, gingival index, bleeding on probing, periodontal inflamed surface area (PISA), periodontal epithelial surface area (PESA), radiographic relative bone loss, restorative performance according to modified USPHS criteria, tooth survival, splint survival, and patient satisfaction were evaluated at baseline and after 1, 3, 6, and 12 months.
The findings are expected to provide evidence regarding the short-term clinical effectiveness, periodontal compatibility, restorative performance, and patient-centered outcomes of intracoronal polyethylene fiber-reinforced periodontal splints in the management of periodontally compromised mobile anterior teeth.
- Conditions
- Periodontitis, Tooth Mobility
- Being tested
- Intracoronal Fiber-Reinforced Periodontal Splint
- Keywords
- Periodontitis, Tooth mobility, Periodontal splint, Fiber-reinforced splint, Polyethylene fiber, Periodontal therapy
- Medical subject headings
- Periodontitis, Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronal Fiber-Reinforced Periodontal SplintDevice
Intracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-Reinforced Periodontal Splint Group | Participants with periodontally compromised anterior teeth and pathologic tooth mobility who received intracoronal ultra-high molecular weight polyethylene fiber-reinforced periodontal splints following active periodontal therapy. Receives: Device: Intracoronal Fiber-Reinforced Periodontal Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth survival
Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.
Measured: Baseline to 12 months
Secondary outcomes (10)
Visual Analog Scale
Patient satisfaction assessed using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater satisfaction.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Modified USPHS criteria
Clinical evaluation of restorative performance using modified USPHS criteria, including anatomical form, marginal adaptation, marginal discoloration, surface texture, color match, secondary caries, and retention.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Relative radiographic bone loss
Relative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.
Measured: Baseline, 6 months, and 12 months
Probing Pocket Depth (PPD)
Mean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.
Measured: Baseline, 6 months, and 12 months
Clinical Attachment Level (CAL)
Mean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.
Measured: Baseline, 6 months, and 12 months
Plaque Index (PI)
Plaque accumulation assessed using the Silness and Löe Plaque Index.
Measured: Baseline, 6 months, and 12 months
Gingival Index (GI)
Gingival inflammation assessed using the Löe and Silness Gingival Index.
Measured: Baseline, 6 months, and 12 months
Bleeding on Probing (BOP)
Bleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.
Measured: Baseline, 6 months, and 12 months
Periodontal Inflamed Surface Area (PISA)
Periodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.
Measured: Baseline, 6 months, and 12 months
Periodontal Epithelial Surface Area (PESA)
Periodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Jul 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emre Taşlı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Taşlı, Selcuk University
- Investigators
- Emine Elif Mutafcılar Velioğlu, DDS, Principal investigator, Selcuk University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729904
- Sponsor's protocol ID
- SU-ET-2024-28
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
- ClinicalTrials.gov ID
- NCT07729904
- Acronym / sponsor ID
- SU-ET-2024-28
- Conditions
- Periodontitis, Tooth Mobility
- Keywords
- Periodontitis, Tooth mobility, Periodontal splint, Fiber-reinforced splint, Polyethylene fiber, Periodontal therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emre TaşlıUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
Periodontal disease may cause loss of supporting tissues and increased tooth mobility, particularly in the anterior region, leading to functional and esthetic problems. Fiber-reinforced periodontal splinting is used to stabilize mobile teeth and improve patient comfort while preserving natural dentition. The aim of this study is to evaluate the 12-month clinical performance of intracoronal ultra-high molecular weight polyethylene fiber-reinforced periodontal splints in periodontally compromised anterior teeth. Periodontal, restorative, radiographic, and patient-reported outcomes will be assessed at baseline and during follow-up visits at 1, 3, 6, and 12 months.
Detailed description
Periodontal attachment loss may result in pathologic tooth mobility, compromising function, esthetics, and quality of life. Periodontal splinting is commonly used as an adjunctive treatment to stabilize mobile teeth following periodontal therapy. However, evidence regarding the long-term periodontal and restorative performance of intracoronal fiber-reinforced splints remains limited.
This prospective observational cohort study evaluates the clinical performance of intracoronal periodontal splints fabricated with ultra-high molecular weight polyethylene fiber in periodontally compromised anterior teeth. Patients received comprehensive periodontal therapy before splint placement. Clinical periodontal parameters, including probing depth, clinical attachment level, plaque index, gingival index, bleeding on probing, periodontal inflamed surface area (PISA), periodontal epithelial surface area (PESA), radiographic relative bone loss, restorative performance according to modified USPHS criteria, tooth survival, splint survival, and patient satisfaction were evaluated at baseline and after 1, 3, 6, and 12 months.
The findings are expected to provide evidence regarding the short-term clinical effectiveness, periodontal compatibility, restorative performance, and patient-centered outcomes of intracoronal polyethylene fiber-reinforced periodontal splints in the management of periodontally compromised mobile anterior teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiber-Reinforced Periodontal Splint Group | – | Device: Intracoronal Fiber-Reinforced Periodontal SplintParticipants with periodontally compromised anterior teeth and pathologic tooth mobility who received intracoronal ultra-high molecular weight polyethylene fiber-reinforced periodontal splints following active periodontal therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with periodontitis presenting with pathologic mobility of one or more anterior teeth due to periodontal attachment loss who received intracoronal ultra-high molecular weight polyethylene fiber (Ribbond®) periodontal splinting following active periodontal therapy at the Faculty of Dentistry, Selcuk University.
Key inclusion criteria (2 listed)
- Adults aged 18 years or older. Presence of at least one maxillary or mandibular anterior tooth with pathologic mobility due to periodontal attachment loss requiring intracoronal ultra-high molecular weight polyethylene fiber (Ribbond®) splinting, performed as an adjunct to non-surgical (Phase I) or surgical (Phase II) periodontal therapy, or following completion of periodontal therapy.
- Willingness to attend all scheduled follow-up visits during the study period. Provision of written informed consent.
Key exclusion criteria (2 listed)
- Age younger than 18 years. Pregnancy. Splint placement performed for dentoalveolar trauma rather than periodontal attachment loss.
- History of chemotherapy, radiotherapy, or immunosuppressive therapy. Temporary splinting intended only for provisional periodontal stabilization. Splinting performed using materials other than ultra-high molecular weight polyethylene fiber (Ribbond®), including wire-composite or composite-only splints.
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 |
|---|---|---|
| Intracoronal Fiber-Reinforced Periodontal SplintIntracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy. | Device | Fiber-Reinforced Periodontal Splint Group |
Primary outcome
Tooth survival
Time frame: Baseline to 12 months
Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.
10 secondary outcomes
Visual Analog Scale
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Modified USPHS criteria
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Relative radiographic bone loss
Time frame: Baseline, 6 months, and 12 months
Probing Pocket Depth (PPD)
Time frame: Baseline, 6 months, and 12 months
Clinical Attachment Level (CAL)
Time frame: Baseline, 6 months, and 12 months
Plaque Index (PI)
Time frame: Baseline, 6 months, and 12 months
Gingival Index (GI)
Time frame: Baseline, 6 months, and 12 months
Bleeding on Probing (BOP)
Time frame: Baseline, 6 months, and 12 months
Periodontal Inflamed Surface Area (PISA)
Time frame: Baseline, 6 months, and 12 months
Periodontal Epithelial Surface Area (PESA)
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Emine Elif Mutafcılar Velioğlu, DDS principal investigator
Selcuk University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Tooth Mobility, run by Emre Taşlı 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 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tooth survival (time frame: Baseline to 12 months). 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 28 Jul 2026.