PeriodontitisPhase 4NCT07459049
"Effect of Ibuprofen on Acute Inflammatory Response After One-Stage Periodontal Therapy"
A Phase 4 study testing Non surgical root surface debridement in one stage without receiving Ibuprofen and Non surgical root surface debridement in one stage with receiving Ibuprofen in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non surgical root surface debridement in one stage without receiving Ibuprofen and Non surgical root surface debridement in one stage with receiving Ibuprofen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2025to Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 .
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad
Baghdad, 10047
College of Dentistry, University of Baghdad, 0096414169394, master@codental.uobaghdad.edu.iq
Nabaa Ismail Ibrahim, B.D.S
About this study
Official title: Efficacy Of Ibuprofen In Reducing Acute Inflammatory Response Following One Stage Non- Surgical Periodontal Therapy (A Randomized Clinical 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?"
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Non surgical root surface debridement in one stage without receiving Ibuprofen, Non surgical root surface debridement in one stage with receiving Ibuprofen
- Keywords
- Ibuprofen, Acute inflammatory response, One stage periodontal therapy, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical root surface debridement in one stage without receiving IbuprofenProcedure or 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Undergo Conventional Non-Surgical Periodontal Therapy and not receiving Ibuprofen | Active comparator | Not described Receives: Procedure: Non surgical root surface debridement in one stage without receiving Ibuprofen |
| Test group: Undergo Conventional Non-Surgical Periodontal Therapy and receiving Ibuprofen | Experimental | Not described Receives: Drug: Non surgical root surface debridement in one stage with receiving Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
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
Measured: 7 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabaa Ismail Ibrahim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459049
- Sponsor's protocol ID
- 1121
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Ibuprofen In Reducing Acute Inflammatory Response Following One Stage Non- Surgical Periodontal Therapy (A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT07459049
- Acronym / sponsor ID
- 1121
- Conditions
- Periodontitis
- Keywords
- Ibuprofen, Acute inflammatory response, One stage periodontal therapy, Non-surgical periodontal therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical root surface debridement in one stage without receiving IbuprofenControl 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. | Procedure or surgery | Control group: Undergo Conventional Non-Surgical Periodontal Therapy and not receiving Ibuprofen |
| Non surgical root surface debridement in one stage with receiving IbuprofenTest 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. | Drug | Test group: Undergo Conventional Non-Surgical Periodontal Therapy and receiving Ibuprofen |
Primary outcome
Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy.
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
1 secondary outcome
Change in postoperative pain measured using Visual Analog Scale (VAS).
Time frame: 7 days after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non surgical root surface debridement in one stage without receiving Ibuprofen and Non surgical root surface debridement in one stage with receiving Ibuprofen in people with Periodontitis, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabaa Ismail Ibrahim, B.D.S (009647740580458, naba.ismail2405@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic inflammatory biomarkers (hs-CRP, IL-6, and Procalcitonin) following one-stage non-surgical periodontal therapy. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.