Gulf Medical University
Ajman, Ajman Emirate, 4184, United Arab Emirates
Location contact
Hanen El Shawia, MDS
PRINCIPAL_INVESTIGATOR
Mohamed Atef, Ph.D.
CONTACT
Mohamed Atef, Ph.D.
SUB_INVESTIGATOR
CONTACT
NCT Number: NCT07090265
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.
Trial opening soon.
Get NotifiedUp to 70 year
All sexes
Interventional
Phase 3
Ajman, Ajman Emirate, 4184, United Arab Emirates
Hanen El Shawia, MDS
PRINCIPAL_INVESTIGATOR
Mohamed Atef, Ph.D.
CONTACT
Mohamed Atef, Ph.D.
SUB_INVESTIGATOR
CONTACT
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.
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
Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes
Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes following by subgingival application of I-PRF
Time frame: 3 months
the change in the distance from the Cemento-Enamel Junction to the base of the periodontal pockets
Time frame: 3 months
The change in the distance from the gingival margin to the base of the periodontal pocket
Time frame: 3 months
the response to the walking of the probe on the lateral wall of the periodontal pocket
Contact information is provided by the study sponsor or research team.
Cairo University
Other
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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