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临床试验/NCT07459049
NCT07459049招募中4 期

Efficacy Of Ibuprofen In Reducing Acute Inflammatory Response Following One Stage Non- Surgical Periodontal Therapy (A Randomized Clinical Trial )

University of Baghdad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy.

研究概览

简要总结

The goal of this ( Clinical Trial ) is to evaluate the efficacy of Ibuprofen in reducing acute inflammatory response (hs-CRP, ProCT, IL-6) after one hour and one week following one stage non surgical periodontal therapy.

The main question it aims to answer is:

"Does Ibuprofen effectively reduce the acute inflammatory response ( hs-CRP, ProCT, IL-6) following one-stage non-surgical periodontal therapy?"

详细描述

Baseline visit including: Demographic Data Collection , Clinical Examination/ Recording Clinical Parameters and Baseline serum samples will be collected from all participants .Scaling will be performed for all participants, followed by the provision of oral hygiene instructions and patient motivation to ensure proper plaque control.

All participants will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids.

Interventional visit: After one week from baseline visit the clinical periodontal parameters will be recorded again. Subsequently, Test group will receive multiple doses of (400mg ) of an anti-inflammatory drug (Ibuprofen) . The first dose will be administered one hour before root surface debridement and the subsequent doses will be taken 3 times daily for a duration of 3 days after RSD , while Control group will not receive Ibuprofen. Full mouth root surface debridment will performed for all participants by a single periodontist, using area specific (Gracey) curettes (Medesy, Italy) , local anaesthesia will be given only when needed. For both groups, treatment duration will be recorded using a digital stopwatch starting from the moment of the first contact between instrument and tooth surface until the end of the clinical procedure (2 h) . During clinical sessions, several breaks will be given to the patients in order to allow the patients to get rest whenever they feel tired during the session.

Follow up visit: after 1 week from Root surface debridement Serum samples will be collected , visual analogue scale questionnaire will be used , the plaque index will also be recorded at this visit for comparison with baseline values to ensure patients compliance for oral hygiene motivation and instruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • systemically healthy patients.
  • having a minimum of 20 teeth.
  • Generalized unstable periodontitis.
  • Pocket depth [≥ 4 mm].
  • All included participants should be adults aged more than 18 years .
  • smokers and non smokers

排除标准

  • Allergy or hypersensitivity to Ibuprofen or other NSAIDs.
  • current systemic anti-inflammatory or antibiotic therapy (<3 months).
  • peptic ulcer disease.
  • recent periodontal therapy (<3 months).
  • Renal impairment .
  • Hepatic impairment.
  • Severe cardiac disease (heart failure, hypertension (.
  • Bleeding disorders (e.g., hemophilia) or patients taking anticoagulants .
  • Any participant who had known or suspected high risk for tuberculosis, hepatitis B or HIV infections.
  • pregnant or lactating females.
  • those being unable to provide written informed consent.

研究组 & 干预措施

Control group: Undergo Conventional Non-Surgical Periodontal Therapy and not receiving Ibuprofen

Active Comparator

干预措施: Non surgical root surface debridement in one stage without receiving Ibuprofen (Procedure)

Test group: Undergo Conventional Non-Surgical Periodontal Therapy and receiving Ibuprofen

Experimental

干预措施: Non surgical root surface debridement in one stage with receiving Ibuprofen (Drug)

结局指标

主要结局

Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy.

时间窗: 7 days

Systemic inflammatory response will be evaluated by measuring serum levels of high sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and Procalcitonin (ProCT). Venous blood samples will be collected at baseline (at baseline visit), 1 hour after completion of non-surgical periodontal therapy (Root surface debridement visit), and 7 days after treatment. Biomarker concentrations will be analyzed using the enzyme-linked immunosorbent assay (ELISA) method to determine changes in systemic inflammatory response. Unit of Measure hs-CRP: mg/L IL-6: pg/mL Procalcitonin: ng/mL

次要结局

  • Change in postoperative pain measured using Visual Analog Scale (VAS).(7 days after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nabaa Ismail Ibrahim

Principal Investigator

University of Baghdad

研究点 (1)

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