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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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

50

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 突尼斯
    • Mont Fleury
      • Tunis、Mont Fleury、突尼斯、1008
        • 招聘中
        • Military Hospital of Instruction of Tunis
        • 接触：
        • 首席研究员：
          • hedi chouchene, DDS
        • 首席研究员：
          • yasmine rjab, DDS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：I-PRF
Quadrants randomly assigned to receive I-PRF irrigation after SRP
生物：Injectable Platelet-Rich Fibrin (I-PRF)
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
程序：Scaling and Root Planing
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.
实验性的：Povidone-Iodine
Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP
程序：Scaling and Root Planing
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.
药品：Povidone-Iodine Irrigation (1%)
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.
实验性的：Diode Laser
Quadrants randomly assigned to receive diode laser activation after SRP
程序：Scaling and Root Planing
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.
设备：Diode Laser Activation
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
假比较器：Saline Control
Quadrants randomly assigned to receive 0.9% saline irrigation after SRP
程序：Scaling and Root Planing
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.
程序：Saline Irrigation (0.9%)
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Bleeding on Probing (BOP)
大体时间：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)
大体时间：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.
Baseline, 3 months, and 6 months
Clinical Attachment Level (CAL)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Military Hospital of Tunis

调查人员

  • 研究主任：Hela Jegham, DDS -Professor、Military Hospital of Instruction of Tunis
  • 首席研究员：hedi chouchene, DDS、Military Hospital of Instruction of Tunis
  • 研究主任：Rym masmoudi, DDS - Associate Professor、Military Hospital of Instruction of Tunis
  • 首席研究员：yassmine rjeb, DDS、Military Hospital of Instruction of Tunis

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月25日

初级完成 (估计的)

2027年5月18日

研究完成 (估计的)

2027年5月18日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MilitaryHosp Tunis

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

Beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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