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Active, Not Recruiting

NCT Number: NCT07375004

Injectable PRF in Non-Surgical Periodontal Treatment

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 .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Periodontitis Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Periodontal Pocket Stomatognathic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustansiriyah University, College of Dentistry.

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injectable Platelet-Rich Fibrin (i-PRF).

Biological

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: Autologous Platelet Concentrate., i-PRF

Scaling and Root Planing (SRP).

Procedure

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: Non surgical periodontal therapy, SRP, Initial periodontal therapy, Phase I periodontal therapy, Cause related periodontal therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Acronym: IPRF-PERIO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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