Injectable PRF in Non-Surgical Periodontal Treatment (IPRF-PERIO)

January 28, 2026 updated by: Thuraya ayad taher al-jubori, Al-Mustansiriyah University

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Mustansiriyah University, College of Dentistry.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: i-PRF + 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
Biological: Injectable Platelet-Rich Fibrin (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
Other Names:
  • i-PRF
  • Autologous Platelet Concentrate.
Procedure: Scaling and Root Planing (SRP).
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
Other Names:
  • SRP
  • Non surgical periodontal therapy
  • Initial periodontal therapy
  • Phase I periodontal therapy
  • Cause related periodontal therapy
Active Comparator: Active Comparator: SRP Alone
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.
Procedure: Scaling and Root Planing (SRP).
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
Other Names:
  • SRP
  • Non surgical periodontal therapy
  • Initial periodontal therapy
  • Phase I periodontal therapy
  • Cause related periodontal therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, and 3 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level (CAL)
Time Frame: Baseline, 1 month, and 3 months post-intervention
Measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket in millimeters.
Baseline, 1 month, and 3 months post-intervention
Bleeding on Probing (BOP)
Time Frame: Baseline, 1 month, and 3 months post intervention
Assessment of the presence or absence of bleeding within 30 seconds after probing, recorded as a percentage of total sites.
Baseline, 1 month, and 3 months post intervention
Plaque Index (PI)
Time Frame: Baseline, 1 month, and 3 months post intervention .
Assessment of the amount of dental plaque on the tooth surfaces to evaluate the patient's oral hygiene during the study.
Baseline, 1 month, and 3 months post intervention .
Microbiological Analysis (Bacterial Load)
Time Frame: Baseline, 1 month, and 3 months post intervention
Quantification of subgingival periodontal pathogens (P. gingivalis and F. nucleatum )using Quantitative Real-time PCR (qPCR) from subgingival plaque samples.
Baseline, 1 month, and 3 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Mustansiriyah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UOM-DENT-ETHIC-2026-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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