Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Konya
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Konya, Konya, Turecko (Türkiye), 42250
- Selcuk University Faculty of Dentistry
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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Intracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tooth survival
Časové okno: Baseline to 12 months
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Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.
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Baseline to 12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual Analog Scale
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months
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Patient satisfaction assessed using a 10-cm Visual Analog Scale (VAS), with higher scores indicating greater satisfaction.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Modified USPHS criteria
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months
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Clinical evaluation of restorative performance using modified USPHS criteria, including anatomical form, marginal adaptation, marginal discoloration, surface texture, color match, secondary caries, and retention.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Relative radiographic bone loss
Časové okno: Baseline, 6 months, and 12 months
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Relative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.
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Baseline, 6 months, and 12 months
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Probing Pocket Depth (PPD)
Časové okno: Baseline, 6 months, and 12 months
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Mean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.
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Baseline, 6 months, and 12 months
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Clinical Attachment Level (CAL)
Časové okno: Baseline, 6 months, and 12 months
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Mean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.
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Baseline, 6 months, and 12 months
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Plaque Index (PI)
Časové okno: Baseline, 6 months, and 12 months
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Plaque accumulation assessed using the Silness and Löe Plaque Index.
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Baseline, 6 months, and 12 months
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Gingival Index (GI)
Časové okno: Baseline, 6 months, and 12 months
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Gingival inflammation assessed using the Löe and Silness Gingival Index.
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Baseline, 6 months, and 12 months
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Bleeding on Probing (BOP)
Časové okno: Baseline, 6 months, and 12 months
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Bleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.
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Baseline, 6 months, and 12 months
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Periodontal Inflamed Surface Area (PISA)
Časové okno: Baseline, 6 months, and 12 months
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Periodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.
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Baseline, 6 months, and 12 months
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Periodontal Epithelial Surface Area (PESA)
Časové okno: Baseline, 6 months, and 12 months
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Periodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.
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Baseline, 6 months, and 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emine Elif Mutafcılar Velioğlu, DDS, Selcuk University Faculty of Dentistry
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SU-ET-2024-28
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