NCT07729904

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress96%
Jul 2024Sep 2026

Study Start

First participant enrolled

July 1, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

July 21, 2026

Last Update Submit

July 27, 2026

Conditions

PeriodontitisTooth Mobility

Keywords

PeriodontitisTooth mobilityPeriodontal splintFiber-reinforced splintPolyethylene fiberPeriodontal therapy

Outcome Measures

Primary Outcomes (1)

  • Tooth survival

    Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.

    Baseline to 12 months

Secondary Outcomes (10)

  • Visual Analog Scale

    Baseline, 1 month, 3 months, 6 months, and 12 months

  • Modified USPHS criteria

    Baseline, 1 month, 3 months, 6 months, and 12 months

  • Relative radiographic bone loss

    Baseline, 6 months, and 12 months

  • Probing Pocket Depth (PPD)

    Baseline, 6 months, and 12 months

  • Clinical Attachment Level (CAL)

    Baseline, 6 months, and 12 months

  • +5 more secondary outcomes

Study Arms (1)

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.

Device: Intracoronal Fiber-Reinforced Periodontal Splint

Interventions

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.

Fiber-Reinforced Periodontal Splint Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Faculty of Dentistry

Konya, Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisTooth Mobility

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Emine Elif Mutafcılar Velioğlu, DDS

    Selcuk University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 28, 2026

Study Start

July 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)