College of Dentistry, University of Baghdad
Baghdad, 10047, Iraq
Location status: Recruiting
NCT Number: NCT07459049
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?"
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Baghdad, 10047, Iraq
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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
Time frame: 7 days after treatment.
Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded after treatment and during the 7-day follow-up period to evaluate the effect of ibuprofen on pain levels
Interested in participating?
Request InfoUniversity of Baghdad
Other
Efficacy Of Ibuprofen In Reducing Acute Inflammatory Response Following One Stage Non- Surgical Periodontal Therapy (A Randomized Clinical Trial )
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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