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Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints

Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07729904
Enrollment
68
Registered
2026-07-28
Start date
2024-07-01
Completion date
2026-09-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Tooth Mobility

Keywords

Periodontitis, Tooth mobility, Periodontal splint, Fiber-reinforced splint, Polyethylene fiber, Periodontal therapy

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.

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.

Interventions

DEVICEIntracoronal Fiber-Reinforced Periodontal Splint

Intracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy.

Sponsors

Emre Taşlı
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Tooth survivalBaseline to 12 monthsNumber and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.

Secondary

MeasureTime frameDescription
Visual Analog ScaleBaseline, 1 month, 3 months, 6 months, and 12 monthsPatient satisfaction assessed using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater satisfaction.
Modified USPHS criteriaBaseline, 1 month, 3 months, 6 months, and 12 monthsClinical evaluation of restorative performance using modified USPHS criteria, including anatomical form, marginal adaptation, marginal discoloration, surface texture, color match, secondary caries, and retention.
Relative radiographic bone lossBaseline, 6 months, and 12 monthsRelative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.
Probing Pocket Depth (PPD)Baseline, 6 months, and 12 monthsMean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.
Clinical Attachment Level (CAL)Baseline, 6 months, and 12 monthsMean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.
Plaque Index (PI)Baseline, 6 months, and 12 monthsPlaque accumulation assessed using the Silness and Löe Plaque Index.
Gingival Index (GI)Baseline, 6 months, and 12 monthsGingival inflammation assessed using the Löe and Silness Gingival Index.
Bleeding on Probing (BOP)Baseline, 6 months, and 12 monthsBleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.
Periodontal Inflamed Surface Area (PISA)Baseline, 6 months, and 12 monthsPeriodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.
Periodontal Epithelial Surface Area (PESA)Baseline, 6 months, and 12 monthsPeriodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREmine Elif Mutafcılar Velioğlu, DDS

Selcuk University Faculty of Dentistry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026