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

NCT ID: NCT07090265

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Periodontitis (Stage 3)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-surgical Periodontal Therapy

Non-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes

Group Type: ACTIVE_COMPARATOR

non-surgical periodontal therapy

Intervention Type: PROCEDURE

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

Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin

Non-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes with adjunctive use of Injectable Platelet Rich Fibrin

Group Type: EXPERIMENTAL

non-surgical periodontal therapy + I-PRF

Intervention Type: PROCEDURE

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

Interventions

non-surgical periodontal therapy

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

Intervention Type: PROCEDURE

non-surgical periodontal therapy + I-PRF

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gulf Medical University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Atef Abd El Moneium

Assistant Professor of Periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Atef, Ph.D.

Role: STUDY_DIRECTOR

Gulf Medical University

Locations

Gulf Medical University

Ajman, Ajman, United Arab Emirates

Countries

United Arab Emirates

Central Contacts

Mohamed Atef, Ph.D

Role: CONTACT

dr.mohamedatef@gmu.ac.ae

+971581069908

Facility Contacts

Mohamed Atef, Ph.D.

Role: primary

dr.mohamedatef@gmu.ac.ae

0581069908

Role: backup

dr.mohamedatef@gmu.ac.ae

Other Identifiers

IRB-COD-STD-71-FEB-2024

Identifier Type: -

Identifier Source: org_study_id