Comparison of MIST With PRF and GBT With PRF in the Treatment of Intrabony Periodontal Defect. A Prospective RCT

NCT06768424 | Recruiting DMC

• 1 other identifier: OGYÉI/55689-5/2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a MIST procedure combined with PRF, or GBT combined with PRF. Clinical, radiological evaluation of the regenerative surgical method and the GBT non-surgical therapy in solitaire deep intrabony periodontal defect.

Conditions

Intrabony Periodontal Defect

Keywords

Guided biofilm terapy; Platelet Rich Fibrine

Outcome Measures

Primary Outcomes (1)

• Intrabony fill

  The change of the intrabony component compared to the initial intrabony defect depth (in percentage), which is measured on standardised individualised x-ray.

  6 months

Secondary Outcomes (3)

• PPD

  6 months

• GR

  6 months

• CAL

  6 months

Study Arms (3)

Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine

EXPERIMENTAL

Non surgical treatment performed to clean and decontaminate the intrabony defect, and filled with PRF

Device: Guided biofilm therapy; Procedure: Platelet Rich Fibrin

Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrine

EXPERIMENTAL

Surgical procedure: Minimal invasive surical approach Platelet rich fibrine chops is used in order to fill the intrabony gap.

Procedure: Platelet Rich Fibrin; Procedure: Minimally Invasive Surgical Technique

Control group

ACTIVE COMPARATOR

The control group patients are treated only with guided biofilm therapy alone

Device: Guided biofilm therapy

Interventions

Guided biofilm therapy DEVICE

Use of Airflow Plus powder subgingivally on teeth with deep periodeontal pockets

Control group; Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine

Platelet Rich Fibrin PROCEDURE

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine; Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrine

Minimally Invasive Surgical Technique PROCEDURE

Periodontal intrabony defect is treated by minimally invasive surgical intervention

Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• solitaire intrabony periodontal defect at least 4 mm

You may not qualify if:

• Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation \> 25°,
• The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
• Patients must not be heavy smokers (\<5 cigarettes/day).
• furcation involvement
• Full mouth plaque and bleeding scores (FMPS and FMBS) of \<15% (O'Leary et al. 1972).
• The patient is able to fully understand the nature of the study, signed informed consent.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, Budapest, 1088, Hungary

RECRUITING

Related Publications (4)

• Miron RJ, Moraschini V, Fujioka-Kobayashi M, Zhang Y, Kawase T, Cosgarea R, Jepsen S, Bishara M, Canullo L, Shirakata Y, Gruber R, Ferenc D, Calasans-Maia MD, Wang HL, Sculean A. Use of platelet-rich fibrin for the treatment of periodontal intrabony defects: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2461-2478. doi: 10.1007/s00784-021-03825-8. Epub 2021 Feb 20.

  PMID: 33609186 BACKGROUND

• Patel GK, Gaekwad SS, Gujjari SK, S C VK. Platelet-Rich Fibrin in Regeneration of Intrabony Defects: A Randomized Controlled Trial. J Periodontol. 2017 Nov;88(11):1192-1199. doi: 10.1902/jop.2017.130710. Epub 2017 Aug 18.

  PMID: 28820322 BACKGROUND

• Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017 Feb;23(1):83-99. doi: 10.1089/ten.TEB.2016.0233. Epub 2016 Oct 10.

  PMID: 27672729 BACKGROUND

• Cortellini P, Cortellini S, Bonaccini D, Tonetti MS. Modified minimally invasive surgical technique in human intrabony defects with or without regenerative materials-10-year follow-up of a randomized clinical trial: Tooth retention, periodontitis recurrence, and costs. J Clin Periodontol. 2022 Jun;49(6):528-536. doi: 10.1111/jcpe.13627. Epub 2022 Apr 25.

  PMID: 35415940 BACKGROUND

Central Study Contacts

Pál Nagy, DMD

CONTACT

+3613185222; kardpali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: January 10, 2025
• Study Start: December 20, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)