"Effect of Ibuprofen on Acute Inflammatory Response After One-Stage Periodontal Therapy"

Официальное название

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

Обзор

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?"

Подробное описание

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.

Вмешательства

• Процедура Non surgical root surface debridement in one stage without receiving Ibuprofen
  Control group: After one week from baseline visit which include supragingival debridement by using ultrasonic device . sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy). Without receiving Ibuprofen.
• Препарат Non surgical root surface debridement in one stage with receiving Ibuprofen
  Test group: After one week from baseline visit which include supragingival debridement by using ultrasonic device . Test group will receive first dose of Ibuprofen (400 mg) administer one hour before root surface debridement and the subsequent doses will be taken 3 times daily for a duration of 3 days after RSD.

Первичные конечные точки

• Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy. [Срок оценки: 7 days]

Вторичные конечные точки (1)

• Change in postoperative pain measured using Visual Analog Scale (VAS). [Срок оценки: 7 days after treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).
• Asthma.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Ирак · 1 центр

• College of Dentistry, University of Baghdad — Baghdad

Идентификаторы

NCT: NCT07459049 · 1121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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