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

ConditionPeriodontitis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Baghdad

About this trial

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?"

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

systemically healthy patients.

having a minimum of 20 teeth.

Generalized unstable periodontitis.

Pocket depth [≥ 4 mm].

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Non surgical root surface debridement in one stage without receiving Ibuprofen
Procedure/Surgery
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.
Non surgical root surface debridement in one stage with receiving Ibuprofen
Drug
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Control group: Undergo Conventional Non-Surgical Periodontal Therapy and not receiving IbuprofenActive comparator 1 intervention

Group B: Test group: Undergo Conventional Non-Surgical Periodontal Therapy and receiving IbuprofenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Secondary outcomes

Change in postoperative pain measured using Visual Analog Scale (VAS).

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

Time frame

7 days after treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov

Apply now