NCT07459049

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?"

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
2mo left

Started Dec 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Dec 2025Aug 2026

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 26, 2026

Last Update Submit

March 6, 2026

Conditions

Periodontitis

Keywords

IbuprofenAcute inflammatory responseOne stage periodontal therapyNon-surgical periodontal therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    7 days

Secondary Outcomes (1)

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

    7 days after treatment.

Study Arms (2)

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

ACTIVE COMPARATOR
Procedure: Non surgical root surface debridement in one stage without receiving Ibuprofen

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

EXPERIMENTAL
Drug: Non surgical root surface debridement in one stage with receiving Ibuprofen

Interventions

Non surgical root surface debridement in one stage without receiving IbuprofenPROCEDURE

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.

Control group: Undergo Conventional Non-Surgical Periodontal Therapy and not receiving Ibuprofen
Non surgical root surface debridement in one stage with receiving IbuprofenDRUG

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Nabaa Ismail Ibrahim, B.D.S

CONTACT

009647740580458naba.ismail2405@codental.uobaghdad.edu.iq

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 9, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-02

Locations

IR(1)