Treating Intrabony Defect With MINST VS MINST Extended PRF

NCT07836231 | Recruiting DMC

• 1 other identifier: Ext-prf-defect
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Periodontal Intrabony Defects

Keywords

Periodontal intrabony defects; Minimally invasive non-surgical technique (MINST); Extended Platelet-Rich Fibrin (e-PRF); Alb-PRF; Periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months after treatment

Secondary Outcomes (4)

• Clinical Attachment Level (CAL)

  Baseline, 3 months, and 6 months after treatment

• Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe

  Baseline, 3 months, and 6 months after treatment

• Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software

  Baseline and 6 months after treatment

• Patient Satisfaction (VAS)

  During the first postoperative week after treatment

Study Arms (2)

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.

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

Biological: Extended Platelet-Rich Fibrin (e-PRF); Procedure: Modified Minimally Invasive Non-Surgical Technique (MINST)

Interventions

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

MINST + Extended Platelet-Rich Fibrin (e-PRF)

Modified Minimally Invasive Non-Surgical Technique (MINST) PROCEDURE

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.

MINST + Extended Platelet-Rich Fibrin (e-PRF); MINST Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, Giza Governorate, 12613, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 37986559 RESULT

• Fujioka-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.

  PMID: 31959025 RESULT

• Ribeiro 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.

  PMID: 36661203 RESULT

• Nibali 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.

  PMID: 31351492 RESULT

• Nibali 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.

  PMID: 26257238 RESULT

Central Study Contacts

Samuel Michael Mikhail, B.Sc.

CONTACT

+201117776200; samuel.girgis@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Postgraduate Researcher in periodontology

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 23, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start: 6 months after publication of the primary results End: 5 years after publication of the primary results
• Access Criteria: De-identified individual participant data, the study protocol, the statistical analysis plan, and the informed consent form will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be provided after review and approval of the proposal and execution of a data use agreement, with data shared in a secure electronic format.

Locations

EG (1)