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NCT Number: NCT07090265

Evaluation of The Periodontal Parameters Following Non-Surgical Periodontal Therapy With and Without Adjunctive Use of Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effectiveness of non-surgical periodontal therapy (NSPT) with and without the adjunctive use of injectable platelet-rich fibrin (I-PRF) in patients with chronic periodontitis. The primary objective is to assess changes in key periodontal parameters including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) over a defined follow-up period. Participants will be randomly assigned to two groups: one receiving standard NSPT alone and the other receiving NSPT combined with subgingival application of I-PRF. The study seeks to determine whether the adjunctive use of I-PRF can enhance periodontal healing and improve clinical outcomes compared to conventional therapy alone.

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Key information

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gulf Medical University

Ajman, Ajman Emirate, 4184, United Arab Emirates

Location contact

Hanen El Shawia, MDS

PRINCIPAL_INVESTIGATOR

Mohamed Atef, Ph.D.

CONTACT

[email protected]

0581069908

Mohamed Atef, Ph.D.

SUB_INVESTIGATOR

CONTACT

[email protected]

About this study

This randomized controlled clinical trial is designed to assess the clinical efficacy of non-surgical periodontal therapy (NSPT) with and without the adjunctive use of injectable platelet-rich fibrin (I-PRF) in the management of chronic periodontitis. Periodontal disease is a multifactorial inflammatory condition characterized by progressive destruction of the supporting structures of the teeth. NSPT, primarily through scaling and root planing (SRP), remains the gold standard for initial therapy. However, the regeneration of periodontal tissues following NSPT can be limited, especially in moderate to advanced cases.

Injectable PRF (I-PRF) is a second-generation autologous platelet concentrate prepared without anticoagulants, offering a fluid formulation rich in platelets, leukocytes, and growth factors. Its injectable nature allows subgingival delivery, promoting enhanced wound healing and soft tissue regeneration. This study aims to investigate whether adjunctive use of I-PRF following SRP can provide superior clinical outcomes compared to SRP alone.

Participants diagnosed with generalized chronic periodontitis, presenting with probing depths ≥5 mm in at least two quadrants, will be enrolled. Subjects will be randomly allocated into two groups:

Test Group: Undergo NSPT (scaling and root planing) followed by subgingival injection of I-PRF at selected sites.

Control Group: Undergo NSPT alone without any adjunctive treatment.

I-PRF will be prepared via low-speed centrifugation of venous blood immediately prior to application and injected subgingivally at the affected sites immediately after completion of SRP.

Clinical parameters including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be recorded at baseline and at 3 months post-treatment. All procedures and assessments will be performed by calibrated, blinded examiners.

The primary outcome measure is the change in clinical attachment level at 3 months. Secondary outcome measures include reductions in PD and BOP, and improvements in PI. The study will help determine whether I-PRF can serve as a minimally invasive, biologically driven adjunct to enhance the outcomes of conventional NSPT.

This investigation is expected to contribute to evidence-based decision-making regarding the adjunctive use of autologous biologics in periodontal therapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Medically free, Non-smokers, Stage III Periodontitis Patients, Probing depth <5mm

Exclusion criteria

  • Systemic disease, Smoking, Pregnancy, History of Chemotherapy, Radiotherapy

Treatment and study plan

Non-surgical periodontal therapy

Procedure

Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes

non-surgical periodontal therapy + I-PRF

Procedure

Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes following by subgingival application of I-PRF

Primary outcomes

  1. Clinical attachment Gain

    Time frame: 3 months

    the change in the distance from the Cemento-Enamel Junction to the base of the periodontal pockets

Secondary outcomes

  1. Probing Depth Reduction

    Time frame: 3 months

    The change in the distance from the gingival margin to the base of the periodontal pocket

  2. Bleeding on Probing

    Time frame: 3 months

    the response to the walking of the probe on the lateral wall of the periodontal pocket

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Atef, Ph.D

CONTACT

[email protected]

+971581069908

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Gulf Medical University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

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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