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

April 25, 2026 updated by: Pal Nagy, Semmelweis University

Comparison of Minimally Invasive Surgical Therapy in Combination With Platelet Rich Fibrine and Guided Biofilm Therapy Combined With Platelet Rich Fibrine in the Treatment of Solitaire Intrabony Periodontal Defect A Prospective RCT.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study aims to clinically and radiologically evaluate the healing response of the periodontal tissues in there is not opened flap design to access the intrabony defect test 1 group where The pre- surgically prepared Platelet Rich fibrine is added into the previously cleaned defect. In the test 2 group a minimally invasive surgical approach is used to access to the intrabony pocket. After opening a flap the same procedure is used to prepare PRF, and added into the pocket. The pockets in the control Group is only cleaned by guided biofilm therapy. Periodontal clinical parameters measured at baseline and at 6 months serves for secondary. After six months the healing is evaluated with a standardized X-ray holder. The primary outcome value is the delta clinical attachment level (gain or loss) The main interest is how the PRF influence the non-surgical healing. Does it any advance of flap opening procedure in comparison with the GBT, if PRF is used.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis University Department of Periodontology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • solitaire intrabony periodontal defect at least 4 mm

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine
Non surgical treatment performed to clean and decontaminate the intrabony defect, and filled with PRF
Device: Guided biofilm therapy
Use of Airflow Plus powder subgingivally on teeth with deep periodeontal pockets
Procedure: Platelet Rich Fibrin
Pack Platelet Rich Fibrin chops into the intrabony periodontla defect
Experimental: Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrine
Surgical procedure: Minimal invasive surical approach Platelet rich fibrine chops is used in order to fill the intrabony gap.
Procedure: Platelet Rich Fibrin
Pack Platelet Rich Fibrin chops into the intrabony periodontla defect
Procedure: Minimally Invasive Surgical Technique
Periodontal intrabony defect is treated by minimally invasive surgical intervention
Active Comparator: Control group
The control group patients are treated only with guided biofilm therapy alone
Device: Guided biofilm therapy
Use of Airflow Plus powder subgingivally on teeth with deep periodeontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrabony fill
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPD
Time Frame: 6 months
Pocket probing depth measured clinically by calibrated periodontal probe (UNC 15)
6 months
GR
Time Frame: 6 months
Gingival recession measured clinically by calibrated periodontal probe (UNC 15)
6 months
CAL
Time Frame: 6 months
Clinical attachment level measured clinically by calibrated periodontal probe (UNC 15)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OGYÉI/55689-5/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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