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

NCT07090265 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IRB-COD-STD-71-FEB-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis (Stage 3)

Keywords

Periodontitis; Injectable Platelet Rich Fibrib; Non-surgical Periodontal Therapy; Adjunctive Therapy

Outcome Measures

Primary Outcomes (1)

• Clinical attachment Gain

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

  3 months

Secondary Outcomes (2)

• Probing Depth Reduction

  3 months

• Bleeding on Probing

  3 months

Study Arms (2)

Non-surgical Periodontal Therapy

ACTIVE COMPARATOR

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

Procedure: non-surgical periodontal therapy

Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin

EXPERIMENTAL

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

Procedure: non-surgical periodontal therapy + I-PRF

Interventions

non-surgical periodontal therapy PROCEDURE

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

Non-surgical Periodontal Therapy

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

Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Gulf Medical University: collaborator

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 4184, United Arab Emirates

Location

MeSH Terms

Conditions

Periodontitis

Interventions

proliferation regulatory factors, human urine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohamed Atef, Ph.D.

  Gulf Medical University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Atef, Ph.D

CONTACT

+971581069908; dr.mohamedatef@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Periodontics

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

AE (1)