This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients
2026年7月10日 更新者：Hela Jegham、Military Hospital of Tunis
Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial
This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP).
This protocol is designed to be a standardized therapeutic model.
The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit.
The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.
調査の概要
状態
募集
条件
詳細な説明
The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.
- By including smokers, this study addresses "the down to reality " challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation).
- The Smoking Factor:
Investigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.
• Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.
研究の種類
介入
入学 (推定)
50
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hela Jegham, DDS - Professor
- 電話番号：+21654241521
- メール：hela.jegham@yahoo.fr
研究連絡先のバックアップ
- 名前：hedi chouchene, DDS
- 電話番号：+21652042177
- メール：chouchanehadi76@gmail.com
研究場所
-
-
Mont Fleury
-
Tunis、Mont Fleury、チュニジア、1008
- 募集
- Military Hospital of Instruction of Tunis
-
コンタクト：
- hela Jegham, DDS - Professor
- 電話番号：+216 54 241 521
- メール：hela.jegham@yahoo.fr
-
主任研究者：
- hedi chouchene, DDS
-
主任研究者：
- yasmine rjab, DDS
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket > 4 mm minimum in every quadrant.
Exclusion: patients who:
- Pregnant /Lactating
- History of radiotherapy or chemotherapy in the head/neck region.
- Known hypersensitivity to Iodine or Methylene blue solution
- Systematic antibiotic use within the last 30 days
- Long-term use of immunosuppressants or corticosteroids (daily use)
- type 1 / 2 diabetes
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：I-PRF
Quadrants randomly assigned to receive I-PRF irrigation after SRP
|
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes
Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments.
All study quadrants will receive SRP before adjunctive treatment allocation.
|
|
実験的：Povidone-Iodine
Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP
|
Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments.
All study quadrants will receive SRP before adjunctive treatment allocation.
Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula.
|
|
実験的：Diode Laser
Quadrants randomly assigned to receive diode laser activation after SRP
|
Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments.
All study quadrants will receive SRP before adjunctive treatment allocation.
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
|
|
偽コンパレータ：Saline Control
Quadrants randomly assigned to receive 0.9% saline irrigation after SRP
|
Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments.
All study quadrants will receive SRP before adjunctive treatment allocation.
Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula.
This intervention serves as the control treatment for comparison with the adjunctive therapies.
|
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 |
|---|---|---|
|
Bleeding on Probing (BOP)
時間枠：Baseline, 3 months, and 6 months
|
Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe).
The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant.
Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months
|
Baseline, 3 months, and 6 months
|
|
Probing Pocket Depth (PPD)
時間枠：Baseline, 3 months, and 6 months
|
Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, and distolingual/palatal).
Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months.
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Baseline, 3 months, and 6 months
|
|
Clinical Attachment Level (CAL)
時間枠：Baseline, 3 months, and 6 months
|
Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket.
Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 months.
|
Baseline, 3 months, and 6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Hela Jegham, DDS -Professor、Military Hospital of Instruction of Tunis
- 主任研究者：hedi chouchene, DDS、Military Hospital of Instruction of Tunis
- スタディディレクター：Rym masmoudi, DDS - Associate Professor、Military Hospital of Instruction of Tunis
- 主任研究者：yassmine rjeb, DDS、Military Hospital of Instruction of Tunis
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月25日
一次修了 (推定)
2027年5月18日
研究の完了 (推定)
2027年5月18日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MilitaryHosp Tunis
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?
はい
IPD プランの説明
identified individual participant data collected during the study will be shared, including demographic characteristics (age and sex), smoking status, baseline and follow-up periodontal measurements, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), treatment allocation by quadrant, and outcome data used in the primary and secondary analyses.
IPD 共有時間枠
Beginning 6 months after publication of the primary study results and ending 5 years after publication.
IPD 共有アクセス基準
qualified researchers who provide a methodologically sound research proposal.
Requests should be submitted to the principal investigator and will be reviewed in accordance with institutional policies, ethical requirements, and participant confidentiality protections.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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