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NCT Number: NCT07729904

Restorative and Periodontal Evaluation 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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University Faculty of Dentistry

Konya, 42250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracoronal Fiber-Reinforced Periodontal Splint

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Analog Scale

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    Patient satisfaction assessed using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater satisfaction.

  2. Modified USPHS criteria

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    Clinical evaluation of restorative performance using modified USPHS criteria, including anatomical form, marginal adaptation, marginal discoloration, surface texture, color match, secondary caries, and retention.

  3. Relative radiographic bone loss

    Time frame: Baseline, 6 months, and 12 months

    Relative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.

  4. Probing Pocket Depth (PPD)

    Time frame: Baseline, 6 months, and 12 months

    Mean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.

  5. Clinical Attachment Level (CAL)

    Time frame: Baseline, 6 months, and 12 months

    Mean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.

  6. Plaque Index (PI)

    Time frame: Baseline, 6 months, and 12 months

    Plaque accumulation assessed using the Silness and Löe Plaque Index.

  7. Gingival Index (GI)

    Time frame: Baseline, 6 months, and 12 months

    Gingival inflammation assessed using the Löe and Silness Gingival Index.

  8. Bleeding on Probing (BOP)

    Time frame: Baseline, 6 months, and 12 months

    Bleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.

  9. Periodontal Inflamed Surface Area (PISA)

    Time frame: Baseline, 6 months, and 12 months

    Periodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.

  10. Periodontal Epithelial Surface Area (PESA)

    Time frame: Baseline, 6 months, and 12 months

    Periodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.

Sponsors and collaborators

Lead sponsor

Emre Taşlı

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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