Periodontitis (Stage 3)Phase 3NCT07090265
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
A Phase 3 study testing non-surgical periodontal therapy and non-surgical periodontal therapy + I-PRF in people with Periodontitis (Stage 3), run by Cairo University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- non-surgical periodontal therapy and non-surgical periodontal therapy + I-PRF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jul 2025to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medically free, Non-smokers, Stage III Periodontitis Patients, Probing depth <5mm
Who cannot join
- Systemic disease, Smoking, Pregnancy, History of Chemotherapy, Radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
Mohamed Atef, Ph.D., 0581069908, dr.mohamedatef@gmu.ac.ae
dr.mohamedatef@gmu.ac.ae
About this study
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.
Read the 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)
- Being tested
- non-surgical periodontal therapy, non-surgical periodontal therapy + I-PRF
- Keywords
- Periodontitis, Injectable Platelet Rich Fibrib, Non-surgical Periodontal Therapy, Adjunctive Therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapyProcedure or surgery
Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes
non-surgical periodontal therapy + I-PRFProcedure or surgery
Mechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes following by subgingival application of I-PRF
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical Periodontal Therapy | Active comparator | Non-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes Receives: 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 Receives: Procedure: non-surgical periodontal therapy + I-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment Gain
the change in the distance from the Cemento-Enamel Junction to the base of the periodontal pockets
Measured: 3 months
Secondary outcomes (2)
Probing Depth Reduction
The change in the distance from the gingival margin to the base of the periodontal pocket
Measured: 3 months
Bleeding on Probing
the response to the walking of the probe on the lateral wall of the periodontal pocket
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulf Medical University
- Responsible party
- Principal investigator, Mohamed Atef Abd El Moneium, Cairo University
- Investigators
- Mohamed Atef, Ph.D., Study director, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090265
- Sponsor's protocol ID
- IRB-COD-STD-71-FEB-2024
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07090265
- Acronym / sponsor ID
- IRB-COD-STD-71-FEB-2024
- Conditions
- Periodontitis (Stage 3)
- Keywords
- Periodontitis, Injectable Platelet Rich Fibrib, Non-surgical Periodontal Therapy, Adjunctive Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Gulf Medical University
- Study start
- Jul 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical Periodontal Therapy | Active comparator | Procedure: non-surgical periodontal therapyNon-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes |
| Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin | Experimental | Procedure: non-surgical periodontal therapy + I-PRFNon-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes with adjunctive use of Injectable Platelet Rich Fibrin |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medically free, Non-smokers, Stage III Periodontitis Patients, Probing depth <5mm
Key exclusion criteria (1 listed)
- Systemic disease, Smoking, Pregnancy, History of Chemotherapy, Radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-surgical periodontal therapyMechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes | Procedure or surgery | Non-surgical Periodontal Therapy |
| non-surgical periodontal therapy + I-PRFMechanical Root Instrumentation using Ultrasonic scaling and root debridement using Gracey Curettes following by subgingival application of I-PRF | Procedure or surgery | Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin |
Primary outcome
Clinical attachment Gain
Time frame: 3 months
the change in the distance from the Cemento-Enamel Junction to the base of the periodontal pockets
2 secondary outcomes
Probing Depth Reduction
Time frame: 3 months
Bleeding on Probing
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Atef, Ph.D. study director
Gulf Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing non-surgical periodontal therapy and non-surgical periodontal therapy + I-PRF in people with Periodontitis (Stage 3), run by Cairo University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Atef, Ph.D (+971581069908, dr.mohamedatef@gmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment Gain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.