Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Tooth survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Tooth survival
时间窗: Baseline to 12 months
Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.
次要结局
- 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)
- Plaque Index (PI)(Baseline, 6 months, and 12 months)
- Gingival Index (GI)(Baseline, 6 months, and 12 months)
- Bleeding on Probing (BOP)(Baseline, 6 months, and 12 months)
- Periodontal Inflamed Surface Area (PISA)(Baseline, 6 months, and 12 months)
- Periodontal Epithelial Surface Area (PESA)(Baseline, 6 months, and 12 months)
研究者
Emre Taşlı
Research Assistant
Selcuk University