Periodontitis
Conditions
Keywords
Ibuprofen, Acute inflammatory response, One stage periodontal therapy, Non-surgical periodontal therapy
Brief summary
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?"
Detailed description
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.
Interventions
PROCEDURENon 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.
DRUGNon 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.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. systemically healthy patients. 2. having a minimum of 20 teeth. 3. Generalized unstable periodontitis. 4. Pocket depth \[≥ 4 mm\]. 5. All included participants should be adults aged more than 18 years . 6. smokers and non smokers
Exclusion criteria
1. Allergy or hypersensitivity to Ibuprofen or other NSAIDs. 2. current systemic anti-inflammatory or antibiotic therapy (\<3 months). 3. peptic ulcer disease. 4. recent periodontal therapy (\<3 months). 5. Asthma. 6. Renal impairment . 7. Hepatic impairment. 8. Severe cardiac disease (heart failure, hypertension (. 9. Bleeding disorders (e.g., hemophilia) or patients taking anticoagulants . 10. Any participant who had known or suspected high risk for tuberculosis, hepatitis B or HIV infections. 11. pregnant or lactating females. 12. those being unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative pain measured using Visual Analog Scale (VAS). | 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 |
Countries
Iraq
Contacts
CONTACTNabaa Ismail Ibrahim, B.D.S
Outcome results
None listed