Restorative and Periodontal Evaluation of Fiber-Reinforced Periodontal Splints
Restorative And Periodontal Evaluation Of The Success Of Fiber-Reinforced Periodontal Splints
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Konya
-
Konya、Konya、トルコ（Türkiye）、42250
- Selcuk University Faculty of Dentistry
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
Intracoronal fiber-reinforced periodontal splinting using ultra-high molecular weight polyethylene (Ribbond) fibers placed in mobile anterior teeth after completion of active periodontal therapy.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tooth survival
時間枠：Baseline to 12 months
|
Number and percentage of splinted teeth remaining in the oral cavity without extraction during the 12-month follow-up period.
|
Baseline to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual Analog Scale
時間枠：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.
|
Baseline, 1 month, 3 months, 6 months, and 12 months
|
|
Modified USPHS criteria
時間枠：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.
|
Baseline, 1 month, 3 months, 6 months, and 12 months
|
|
Relative radiographic bone loss
時間枠：Baseline, 6 months, and 12 months
|
Relative radiographic bone loss (RBL) assessed on standardized periapical radiographs during follow-up.
|
Baseline, 6 months, and 12 months
|
|
Probing Pocket Depth (PPD)
時間枠：Baseline, 6 months, and 12 months
|
Mean probing pocket depth measured in millimeters using a periodontal probe at six sites per tooth.
|
Baseline, 6 months, and 12 months
|
|
Clinical Attachment Level (CAL)
時間枠：Baseline, 6 months, and 12 months
|
Mean clinical attachment level measured in millimeters using a periodontal probe at six sites per tooth.
|
Baseline, 6 months, and 12 months
|
|
Plaque Index (PI)
時間枠：Baseline, 6 months, and 12 months
|
Plaque accumulation assessed using the Silness and Löe Plaque Index.
|
Baseline, 6 months, and 12 months
|
|
Gingival Index (GI)
時間枠：Baseline, 6 months, and 12 months
|
Gingival inflammation assessed using the Löe and Silness Gingival Index.
|
Baseline, 6 months, and 12 months
|
|
Bleeding on Probing (BOP)
時間枠：Baseline, 6 months, and 12 months
|
Bleeding on probing recorded as the percentage of sites exhibiting bleeding after periodontal probing.
|
Baseline, 6 months, and 12 months
|
|
Periodontal Inflamed Surface Area (PISA)
時間枠：Baseline, 6 months, and 12 months
|
Periodontal inflamed surface area calculated from periodontal clinical measurements according to the validated PISA method.
|
Baseline, 6 months, and 12 months
|
|
Periodontal Epithelial Surface Area (PESA)
時間枠：Baseline, 6 months, and 12 months
|
Periodontal epithelial surface area calculated from periodontal clinical measurements according to the validated PESA method.
|
Baseline, 6 months, and 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Emine Elif Mutafcılar Velioğlu, DDS、Selcuk University Faculty of Dentistry
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SU-ET-2024-28
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。