Platelet-Rich FibrinNCT07613606
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects
A study testing Minimally invasive non-Surgical technique and Minimally invasive non-Surgical technique + platelet-rich fibrin in people with Platelet-Rich Fibrin and Minimally Invasive Non-Surgical Technique, run by October 6 University at 1 site in Egypt.
Trial summary
This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet-Rich Fibrin, Minimally Invasive Non-Surgical Technique, Periodontal Intrabony Defects
- What is being tested?
- Minimally invasive non-Surgical technique and Minimally invasive non-Surgical technique + platelet-rich fibrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.
- Diagnosis of 'periodontitis' stage III (grades B or C).
- Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
- Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.
Who cannot join
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
- Pregnant and lactating women
- Current use of any form of tobacco.
- Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
- Degree 2 or 3 mobility of the involved sites.6.
- Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Cairo, 12511
Amir R Elngar, B.D.S, 00201004634587, amirreda059@gmail.com
Reham L Aggour, MD
About this study
Official title: Injectable Platelet-Rich Fibrin (i-PRF) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated.
Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma.
Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.
- Conditions
- Platelet-Rich Fibrin, Minimally Invasive Non-Surgical Technique, Periodontal Intrabony Defects
- Being tested
- Minimally invasive non-Surgical technique, Minimally invasive non-Surgical technique + platelet-rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive non-Surgical techniqueProcedure or surgery
Patients will receive minimally invasive non-Surgical technique (MINST) alone
Minimally invasive non-Surgical technique + platelet-rich fibrinProcedure or surgery
Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (control group) | Active comparator | Patients will receive minimally invasive non-Surgical technique (MINST) alone Receives: Procedure: Minimally invasive non-Surgical technique |
| Group 2 (Test group) | Experimental | Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection Receives: Procedure: Minimally invasive non-Surgical technique + platelet-rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of comparable bilateral-walled intrabony defects
Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique.
Presence of comparable bilateral-walled intrabony defects (PPD, > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth.
Measured: 6 months postoperatively
Secondary outcomes (5)
Clinical attachment level
Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth
Measured: 6 months postoperatively
Interproximal probing depth
Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth
Measured: 6 months postoperatively
Gingival margin
Gingival margin will be measured from the cemento-enamel junction (CEJ).
Measured: 6 months postoperatively
Bleeding on probing
Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus
Measured: 6 months postoperatively
Plaque index
Plaque index (PI) will be measured for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich FibrinStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Reda Ahmed Mohamed Elngar, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613606
- Sponsor's protocol ID
- 23110280p
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Platelet-Rich Fibrin (i-PRF) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07613606
- Acronym / sponsor ID
- 23110280p
- Conditions
- Platelet-Rich Fibrin, Minimally Invasive Non-Surgical Technique, Periodontal Intrabony Defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 May 2026 (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 study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated.
Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma.
Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control group) | Active comparator | Procedure: Minimally invasive non-Surgical techniquePatients will receive minimally invasive non-Surgical technique (MINST) alone |
| Group 2 (Test group) | Experimental | Procedure: Minimally invasive non-Surgical technique + platelet-rich fibrinPatients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.
- Diagnosis of 'periodontitis' stage III (grades B or C).
- Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
- Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.
Key exclusion criteria (6 listed)
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
- Pregnant and lactating women
- Current use of any form of tobacco.
- Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
- Degree 2 or 3 mobility of the involved sites.6.
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 |
|---|---|---|
| Minimally invasive non-Surgical techniquePatients will receive minimally invasive non-Surgical technique (MINST) alone | Procedure or surgery | Group 1 (control group) |
| Minimally invasive non-Surgical technique + platelet-rich fibrinPatients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection | Procedure or surgery | Group 2 (Test group) |
Primary outcome
Presence of comparable bilateral-walled intrabony defects
Time frame: 6 months postoperatively
Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth.
5 secondary outcomes
Clinical attachment level
Time frame: 6 months postoperatively
Interproximal probing depth
Time frame: 6 months postoperatively
Gingival margin
Time frame: 6 months postoperatively
Bleeding on probing
Time frame: 6 months postoperatively
Plaque index
Time frame: 6 months postoperatively
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 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive non-Surgical technique and Minimally invasive non-Surgical technique + platelet-rich fibrin in people with Platelet-Rich Fibrin and Minimally Invasive Non-Surgical Technique, run by October 6 University at 1 site in Egypt.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 May 2026. 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 Egypt. 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.
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 Amir R Elngar, B.D.S (00201004634587, amirreda059@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of comparable bilateral-walled intrabony defects (time frame: 6 months postoperatively). 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 May 2026.