Injectable PRF in Non-Surgical Periodontal Treatment

NCT07375004 — Not applicable, Completed, 18 participants, Al-Mustansiriyah University

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Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )

RegistryNCT07375004, acronym IPRF-PERIO
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, treatment
Enrollment18 (Actual)
SponsorAl-Mustansiriyah University (Other)
ConditionsPeriodontitis, Periodontal Pocket, Alveolar Bone Loss
InterventionsInjectable Platelet-Rich Fibrin (i-PRF)., Scaling and Root Planing (SRP). (Biological, procedure)
Datesstart 2026-01-29, primary completion 2026-03-29, completion 2026-05-28, first posted 2026-01-29, last updated 2026-10-07
Locations1 site in Iraq

Related Papers Related Patents Related Grants Related Experts
All trials for Periodontitis All trials for Periodontal Pocket All trials of Injectable Platelet-Rich Fibrin (i-PRF). All trials of Scaling and Root Planing (SRP).

-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. 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 .

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental: i-PRF + SRPExperimentalBiological: 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 AloneActive comparatorProcedure: 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.
  • Injectable Platelet-Rich Fibrin (i-PRF). (Biological), also known as 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), also known as Non surgical periodontal therapy, SRP, Initial periodontal therapy, Phase I periodontal therapy, Cause related 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

+Outcome measures

Primary outcomes

  • Change in Probing Pocket Depth (PPD) [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.

Secondary outcomes

  • Clinical Attachment Level (CAL) [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.
  • Bleeding on Probing (BOP) [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.
  • Plaque Index (PI) [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.
  • Microbiological Analysis (Bacterial Load) [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.

+Eligibility

Sex: All, ages: 30 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Mustansiriyah University, College of Dentistry.BaghdadIraq