Selcuk University Faculty of Dentistry
Konya, 42250, Turkey (Türkiye)
NCT Number: NCT07729904
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Konya, 42250, Turkey (Türkiye)
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.
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.
Intracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy.
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.
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.
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.
Time frame: Baseline, 6 months, and 12 months
Relative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.
Time frame: Baseline, 6 months, and 12 months
Mean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.
Time frame: Baseline, 6 months, and 12 months
Mean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.
Time frame: Baseline, 6 months, and 12 months
Plaque accumulation assessed using the Silness and Löe Plaque Index.
Time frame: Baseline, 6 months, and 12 months
Gingival inflammation assessed using the Löe and Silness Gingival Index.
Time frame: Baseline, 6 months, and 12 months
Bleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.
Time frame: Baseline, 6 months, and 12 months
Periodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.
Time frame: Baseline, 6 months, and 12 months
Periodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.
Emre Taşlı
Other
Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
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.
Published trials that share one or more normalized conditions with this study.
NCT06436729
Mouth Diseases, Periodontal Diseases
Rohtak, Haryana, India
View Trial DetailsNCT07141680
Mouth Diseases, Periodontal Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06929676
Mouth Diseases, Periodontal Diseases
Piracicaba, São Paulo, Brazil
View Trial DetailsNCT07693725
Mouth Diseases, Periodontal Diseases
Isparta, Turkey (Türkiye)
View Trial Details