PeriodontitisIPRF-PERIONCT07375004
Injectable PRF in Non-Surgical Periodontal Treatment
A study testing Injectable Platelet-Rich Fibrin (i-PRF). and Scaling and Root Planing (SRP). in people with Periodontitis and Periodontal Pocket, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontitis, Periodontal Pocket, Alveolar Bone Loss
- What is being tested?
- Injectable Platelet-Rich Fibrin (i-PRF). and Scaling and Root Planing (SRP).
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIraq
- Study dates
- 29 Jan 2026to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects aged 30 years and above.
- No history of systemic diseases (e.g., diabetes mellitus).
- Not currently under active periodontal therapy or joining other trial in the last 3 months.
- Diagnosis with Stage II or III Periodontitis.
- presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.
Who cannot join
- Smokers or alcohol users.
- Patients consuming antibiotics or anticoagulants.
- Regular users of non-steroidal anti-inflammatory drugs.
- Receipt of periodontal treatment within 3 months prior to the study.
- Any bleeding or clotting disorders.
- Teeth with Grade II or Grade III furcation involvement.
- Pregnant or breastfeeding mothers.
- Patients unwilling to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )
This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .
Read the detailed description
Patients with periodontitis will be recruited for this split-mouth randomized controlled trial. All participants will receive full-mouth supra and sub-gingival scaling and root planing (SRP). In the intervention side, i-PRF will be injected into the periodontal pockets, while the control side will receive SRP only.
Clinical measurements including Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP) will be recorded. Additionally, microbiological samples will be collected to assess the changes in the subgingival Porphyromonas gingivalis and Fusobacterium nucleatum . Follow-up visits are scheduled at 1 and 3 months post-intervention to assess the adjunctive benefit of i-PRF.
- Conditions
- Periodontitis, Periodontal Pocket, Alveolar Bone Loss
- Being tested
- Injectable Platelet-Rich Fibrin (i-PRF)., Scaling and Root Planing (SRP).
- Keywords
- Injectable Platelet-Rich Fibrin, i-PRF, Scaling and Root Planing, Non-Surgical Periodontal Therapy, Split-mouth design, Microbiological outcomes, Periodontitis, Regeneration, P. gingivalis
- Medical subject headings
- Periodontitis, Periodontal Pocket, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet-Rich Fibrin (i-PRF).Biological
Also called Autologous Platelet Concentrate., i-PRF
Ten ml of whole blood is collected from the participant into plain tubes and immediately centrifuged. The centrifugation protocol follows the low-speed concept (e.g., 700 rpm for 3 minutes). The upper orange-colored liquid (i-PRF) is then collected and injected subgingivally into the periodontal pockets using a 25-gauge needle immediately after scaling and root planing
Scaling and Root Planing (SRP).Procedure or surgery
Also called Non surgical periodontal therapy, SRP, Initial periodontal therapy, Phase I periodontal therapy
Full-mouth non-surgical periodontal therapy including supra and sub-gingival scaling and root planing performed using ultrasonic devices and Gracey curettes to remove dental biofilm and calculus
| Study group | Role | What they receive |
|---|---|---|
| Experimental: i-PRF + SRP | Experimental | This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets Receives: Biological: Injectable Platelet-Rich Fibrin (i-PRF).; Procedure: Scaling and Root Planing (SRP). |
| Active Comparator: SRP Alone | Active comparator | This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention. Receives: Procedure: Scaling and Root Planing (SRP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth.
Measured: Baseline, 1 month, and 3 months post-intervention
Secondary outcomes (4)
Clinical Attachment Level (CAL)
Measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket in millimeters.
Measured: Baseline, 1 month, and 3 months post-intervention
Bleeding on Probing (BOP)
Assessment of the presence or absence of bleeding within 30 seconds after probing, recorded as a percentage of total sites.
Measured: Baseline, 1 month, and 3 months post intervention
Plaque Index (PI)
Assessment of the amount of dental plaque on the tooth surfaces to evaluate the patient's oral hygiene during the study.
Measured: Baseline, 1 month, and 3 months post intervention .
Microbiological Analysis (Bacterial Load)
Quantification of subgingival periodontal pathogens (P. gingivalis and F. nucleatum )using Quantitative Real-time PCR (qPCR) from subgingival plaque samples.
Measured: Baseline, 1 month, and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start29 Jan 2026
- Primary completion29 Mar 2026
- Study completion28 May 2026
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a split-mouth randomized controlled trial. Each participant receives both treatments in different quadrants of the mouth. One quadrant is randomly assigned to the intervention (Scaling and Root Planing + i-PRF) and the contralateral quadrant serves as the control (Scaling and Root Planing alone)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuraya ayad taher al-jubori, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375004
- Sponsor's protocol ID
- MUOSU/POST-202605
- Acronym
- IPRF-PERIO
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT07375004
- Acronym / sponsor ID
- IPRF-PERIO / MUOSU/POST-202605
- Conditions
- Periodontitis, Periodontal Pocket, Alveolar Bone Loss
- Keywords
- Injectable Platelet-Rich Fibrin, i-PRF, Scaling and Root Planing, Non-Surgical Periodontal Therapy, Split-mouth design, Microbiological outcomes, Periodontitis, Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 29 Mar 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 29 Jan 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.
This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .
Detailed description
Patients with periodontitis will be recruited for this split-mouth randomized controlled trial. All participants will receive full-mouth supra and sub-gingival scaling and root planing (SRP). In the intervention side, i-PRF will be injected into the periodontal pockets, while the control side will receive SRP only.
Clinical measurements including Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP) will be recorded. Additionally, microbiological samples will be collected to assess the changes in the subgingival Porphyromonas gingivalis and Fusobacterium nucleatum . Follow-up visits are scheduled at 1 and 3 months post-intervention to assess the adjunctive benefit of i-PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a split-mouth randomized controlled trial. Each participant receives both treatments in different quadrants of the mouth. One quadrant is randomly assigned to the intervention (Scaling and Root Planing + i-PRF) and the contralateral quadrant serves as the control (Scaling and Root Planing alone)
| Arm | Type | Receives |
|---|---|---|
| Experimental: i-PRF + SRP | Experimental | Biological: Injectable Platelet-Rich Fibrin (i-PRF)., Procedure: Scaling and Root Planing (SRP).This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets |
| Active Comparator: SRP Alone | Active comparator | Procedure: Scaling and Root Planing (SRP).This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects aged 30 years and above.
- No history of systemic diseases (e.g., diabetes mellitus).
- Not currently under active periodontal therapy or joining other trial in the last 3 months.
- Diagnosis with Stage II or III Periodontitis.
- presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.
Key exclusion criteria (8 listed)
- Smokers or alcohol users.
- Patients consuming antibiotics or anticoagulants.
- Regular users of non-steroidal anti-inflammatory drugs.
- Receipt of periodontal treatment within 3 months prior to the study.
- Any bleeding or clotting disorders.
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 |
|---|---|---|
| Injectable Platelet-Rich Fibrin (i-PRF).Also: Autologous Platelet Concentrate., i-PRFTen ml of whole blood is collected from the participant into plain tubes and immediately centrifuged. The centrifugation protocol follows the low-speed concept (e.g., 700 rpm for 3 minutes). The upper orange-colored liquid (i-PRF) is then collected and injected subgingivally into the periodontal pockets using a 25-gauge needle immediately after scaling and root planing | Biological | Experimental: i-PRF + SRP |
| Scaling and Root Planing (SRP).Also: Non surgical periodontal therapy, SRP, Initial periodontal therapy, Phase I periodontal therapyFull-mouth non-surgical periodontal therapy including supra and sub-gingival scaling and root planing performed using ultrasonic devices and Gracey curettes to remove dental biofilm and calculus | Procedure or surgery | Active Comparator: SRP Alone, Experimental: i-PRF + SRP |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, 1 month, and 3 months post-intervention
Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth.
4 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, and 3 months post-intervention
Bleeding on Probing (BOP)
Time frame: Baseline, 1 month, and 3 months post intervention
Plaque Index (PI)
Time frame: Baseline, 1 month, and 3 months post intervention .
Microbiological Analysis (Bacterial Load)
Time frame: Baseline, 1 month, and 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Platelet-Rich Fibrin (i-PRF). and Scaling and Root Planing (SRP). in people with Periodontitis and Periodontal Pocket, run by Al-Mustansiriyah University 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 7 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline, 1 month, and 3 months post-intervention). 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 7 Oct 2026.