Periodontal Intrabony DefectsMINST PRFNCT07836231
Treating Intrabony Defect With MINST VS MINST Extended PRF
A study testing Extended Platelet-Rich Fibrin (e-PRF) and Modified Minimally Invasive Non-Surgical Technique (MINST) in people with Periodontal Intrabony Defects, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Intrabony Defects
- What is being tested?
- Extended Platelet-Rich Fibrin (e-PRF) and Modified Minimally Invasive Non-Surgical Technique (MINST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 26 May 2026to 1 Jul 2027
- 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
- Adults aged above 21 years. Clinical diagnosis of Stage III periodontitis. Presence of at least two isolated interproximal intrabony defects located in different quadrants.
- Intrabony defect associated with a single-rooted tooth or mandibular molar without furcation involvement.
- Probing depth (PD) ≥ 6 mm. Radiographic intrabony defect depth between 3 and 7 mm. Absence of periapical pathology at the study site. Absence of acute periodontal infection. Absence of subgingival restorations that could interfere with clinical measurements.
- Absence of Grade II or Grade III tooth mobility. Ability and willingness to provide written informed consent.
Who cannot join
- Pregnancy or lactation. Non-surgical periodontal therapy within the previous 6 months. Surgical periodontal therapy within the previous 12 months. History of radiotherapy to the head and neck region. Current smoking.
- Eligibility note: Former smokers and never-smokers are eligible.
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
Faculty of Dentistry, Cairo University
Giza, Giza Governorate, 12613
Samuel Mikhail, B.Sc., +201117776200, samuel.girgis@dentistry.cu.edu.eg
About this study
Official title: Clinical Effectiveness of Minimally Invasive Non-surgical Technique With or Without Extended Platelets Rich Fibrin in Intrabony Defects: a Randomized Controlled Clinical Trial
This study evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing.
Study Procedures
Read more
Control Group:
Local anesthesia by infiltration at the treatment site
Instrumentation of the root surface up to the bottom of the periodontal pocket
Efforts are made to minimize trauma to soft tissues and interdental papilla using subpapillary access
Cleaning is performed using piezo-electric devices with delicate tips, avoiding aggressive root smoothing or gingival curettage
3-4× magnification loupes are used to improve precision
Intervention Group:
All the above procedures
Followed by injection of e-PRF, a preparation derived from the patient's own blood
Blood is collected in 4 mL tubes and centrifuged at 700 g for 8 minutes
The platelet-poor plasma is heated to create an albumin gel
The remaining buffy coat (rich in platelets and growth factors) is mixed with the cooled albumin gel to form Alb-PRF, which is applied to the defect
- Conditions
- Periodontal Intrabony Defects
- Being tested
- Extended Platelet-Rich Fibrin (e-PRF), Modified Minimally Invasive Non-Surgical Technique (MINST)
- Keywords
- Periodontal intrabony defects, Minimally invasive non-surgical technique (MINST), Extended Platelet-Rich Fibrin (e-PRF), Alb-PRF, Periodontal regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Platelet-Rich Fibrin (e-PRF)Biological
Autologous extended platelet-rich fibrin (e-PRF) prepared from the participant's peripheral blood. Whole blood is centrifuged to obtain liquid platelet-rich fibrin, while the platelet-poor plasma is heated to form denatured albumin gel. The cooled albumin gel is mixed with the liquid platelet-rich fibrin to produce e-PRF, which is applied into the periodontal intrabony defect immediately after completion of the MINST procedure
Modified Minimally Invasive Non-Surgical Technique (MINST)Procedure or surgery
Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage.
| Study group | Role | What they receive |
|---|---|---|
| MINST Alone | Active comparator | Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) alone. The procedure will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. No platelet-rich fibrin or other regenerative biomaterial will be applied. Receives: Procedure: Modified Minimally Invasive Non-Surgical Technique (MINST) |
| MINST + Extended Platelet-Rich Fibrin (e-PRF) | Experimental | Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol Receives: Biological: Extended Platelet-Rich Fibrin (e-PRF); Procedure: Modified Minimally Invasive Non-Surgical Technique (MINST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Depth (PD)
Change in periodontal probing depth (PD), measured in millimeters using a UNC-15 periodontal probe with a standardized probing force. Measurements are obtained using a patient-specific acrylic stent to ensure reproducibility.
Measured: Baseline and 6 months after treatment
Secondary outcomes (4)
Clinical Attachment Level (CAL)
Measured: Baseline, 3 months, and 6 months after treatment
Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe
Measured: Baseline, 3 months, and 6 months after treatment
Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software
Measured: Baseline and 6 months after treatment
Patient Satisfaction (VAS)
0 indicates no pain or discomfort and 10 indicates the worst imaginable pain or discomfort.
Measured: During the first postoperative week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start26 May 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Periodontal Intrabony DefectsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Michael Mikhail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836231
- Sponsor's protocol ID
- Ext-prf-defect
- Acronym
- MINST PRF
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline clinical measurements, outcome measures, and follow-up data.
Publications
Miron RJ, Pikos MA, Estrin NE, Kobayashi-Fujioka M, Espinoza AR, Basma H, Zhang Y. Extended platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):114-130. doi: 10.1111/prd.12537. Epub 2023 Nov 20.
PubMed 37986559Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
PubMed 31959025Ribeiro FV, Mehta JJ, Monteiro MF, Moore J, Casati MZ, Nibali L. Minimal invasiveness in nonsurgical periodontal therapy. Periodontol 2000. 2023 Feb;91(1):7-19. doi: 10.1111/prd.12476. Epub 2023 Jan 20.
PubMed 36661203Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
PubMed 31351492Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
PubMed 26257238
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Minimally Invasive Non-surgical Technique With or Without Extended Platelets Rich Fibrin in Intrabony Defects: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07836231
- Acronym / sponsor ID
- MINST PRF / Ext-prf-defect
- Conditions
- Periodontal Intrabony Defects
- Keywords
- Periodontal intrabony defects, Minimally invasive non-surgical technique (MINST), Extended Platelet-Rich Fibrin (e-PRF), Alb-PRF, Periodontal regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Sep 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 evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing.
Study Procedures
Control Group:
Local anesthesia by infiltration at the treatment site
Instrumentation of the root surface up to the bottom of the periodontal pocket
Efforts are made to minimize trauma to soft tissues and interdental papilla using subpapillary access
Cleaning is performed using piezo-electric devices with delicate tips, avoiding aggressive root smoothing or gingival curettage
3-4× magnification loupes are used to improve precision
Intervention Group:
All the above procedures
Followed by injection of e-PRF, a preparation derived from the patient's own blood
Blood is collected in 4 mL tubes and centrifuged at 700 g for 8 minutes
The platelet-poor plasma is heated to create an albumin gel
The remaining buffy coat (rich in platelets and growth factors) is mixed with the cooled albumin gel to form Alb-PRF, which is applied to the defect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINST Alone | Active comparator | Procedure: Modified Minimally Invasive Non-Surgical Technique (MINST)Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) alone. The procedure will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. No platelet-rich fibrin or other regenerative biomaterial will be applied. |
| MINST + Extended Platelet-Rich Fibrin (e-PRF) | Experimental | Biological: Extended Platelet-Rich Fibrin (e-PRF), Procedure: Modified Minimally Invasive Non-Surgical Technique (MINST)Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged above 21 years. Clinical diagnosis of Stage III periodontitis. Presence of at least two isolated interproximal intrabony defects located in different quadrants.
- Intrabony defect associated with a single-rooted tooth or mandibular molar without furcation involvement.
- Probing depth (PD) ≥ 6 mm. Radiographic intrabony defect depth between 3 and 7 mm. Absence of periapical pathology at the study site. Absence of acute periodontal infection. Absence of subgingival restorations that could interfere with clinical measurements.
- Absence of Grade II or Grade III tooth mobility. Ability and willingness to provide written informed consent.
Key exclusion criteria (2 listed)
- Pregnancy or lactation. Non-surgical periodontal therapy within the previous 6 months. Surgical periodontal therapy within the previous 12 months. History of radiotherapy to the head and neck region. Current smoking.
- Eligibility note: Former smokers and never-smokers are eligible.
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 |
|---|---|---|
| Extended Platelet-Rich Fibrin (e-PRF)Autologous extended platelet-rich fibrin (e-PRF) prepared from the participant's peripheral blood. Whole blood is centrifuged to obtain liquid platelet-rich fibrin, while the platelet-poor plasma is heated to form denatured albumin gel. The cooled albumin gel is mixed with the liquid platelet-rich fibrin to produce e-PRF, which is applied into the periodontal intrabony defect immediately after completion of the MINST procedure | Biological | MINST + Extended Platelet-Rich Fibrin (e-PRF) |
| Modified Minimally Invasive Non-Surgical Technique (MINST)Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage. | Procedure or surgery | MINST + Extended Platelet-Rich Fibrin (e-PRF), MINST Alone |
Primary outcome
Change in Probing Depth (PD)
Time frame: Baseline and 6 months after treatment
Change in periodontal probing depth (PD), measured in millimeters using a UNC-15 periodontal probe with a standardized probing force. Measurements are obtained using a patient-specific acrylic stent to ensure reproducibility.
4 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: Baseline, 3 months, and 6 months after treatment
Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe
Time frame: Baseline, 3 months, and 6 months after treatment
Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software
Time frame: Baseline and 6 months after treatment
Patient Satisfaction (VAS)
Time frame: During the first postoperative week after treatment
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 23 Sep 2026.
- Results publication: PubMed 37986559Miron RJ, Pikos MA, Estrin NE, Kobayashi-Fujioka M, Espinoza AR, Basma H, Zhang Y. Extended platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):114-130. doi: 10.1111/prd.12537. Epub 2023 Nov 20.
- Results publication: PubMed 31959025Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
- Results publication: PubMed 36661203Ribeiro FV, Mehta JJ, Monteiro MF, Moore J, Casati MZ, Nibali L. Minimal invasiveness in nonsurgical periodontal therapy. Periodontol 2000. 2023 Feb;91(1):7-19. doi: 10.1111/prd.12476. Epub 2023 Jan 20.
- Results publication: PubMed 31351492Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
- Results publication: PubMed 26257238Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline clinical measurements, outcome measures, and follow-up data.
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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 Extended Platelet-Rich Fibrin (e-PRF) and Modified Minimally Invasive Non-Surgical Technique (MINST) in people with Periodontal Intrabony Defects, run by Cairo 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 2 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 23 Sep 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 Samuel Michael Mikhail, B.Sc. (+201117776200, samuel.girgis@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Depth (PD) (time frame: Baseline and 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836231, which also lists 5 linked publications.
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 23 Sep 2026.