跳至主要内容
临床试验/NCT06624241
NCT06624241招募中不适用

Clinical Evaluation of Lipo-Curcumin Gel in Association with SRP for the Treatment of Stage III Periodontitis: a Randomized and Controlled Clinical Trial.

G. d'Annunzio University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Pocket Probing Depth (PPD)

研究概览

简要总结

The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.

This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.

Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.

Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with a diagnosis of periodontitis stage III (grades A to C)
  • •on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment
  • •FMPS < 20% at baseline
  • •Furcation not involved
  • •Not Pregnant or Lactating
  • •Signed informed consent

排除标准

  • •Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C>7%, rheumatoid arthritis or any form of immunosuppression
  • •Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
  • •Chronic intake of NSAIDs or steroids, currently

研究组 & 干预措施

SRP alone

Active Comparator

SRP alone will be performed.

干预措施: SRP alone (Procedure)

Discharged Gel + SRP

Active Comparator

After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate

干预措施: Discharged Gel + SRP (Procedure)

Lipo-Curcumin gel + SRP

Experimental

After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate.

干预措施: Lipo-Curcumin gel + SRP (Procedure)

Lipo gel + SRP

Active Comparator

After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate

干预措施: Lipo gel + SRP (Procedure)

结局指标

主要结局

Pocket Probing Depth (PPD)

时间窗: 12 months

Distance between the gingival margin and the bottom of the pocket.

次要结局

  • Clinical Attachment Level (CAL)(12 months)
  • Gingival Recession (GR)(12 months)
  • Full Mouth Plaque Score(12 months)
  • Full Mouth Bleeding Score(12 months)

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Paolantonio

Head of Periodontology

G. d'Annunzio University

研究点 (1)

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