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Intrabony Periodontal DefectNCT06768424

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

A study testing Guided biofilm therapy, Platelet Rich Fibrin and Minimally Invasive Surgical Technique in people with Intrabony Periodontal Defect, run by Semmelweis University at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Intrabony Periodontal Defect
What is being tested?
Guided biofilm therapy, Platelet Rich Fibrin and Minimally Invasive Surgical Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteHungary
Study dates
20 Dec 2023to 20 Dec 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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • solitaire intrabony periodontal defect at least 4 mm

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pál Nagy, DMD contact

+3613185222

kardpali@gmail.com

Hungary1 site, 1 recruiting

  • Semmelweis University Department of Periodontology

    Budapest, Budapest, 1088

    Pal Nagy, DMD, +3613185222, kardpali@gmail.com

    Recruiting

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
Guided biofilm therapy, Platelet Rich Fibrin, Minimally Invasive Surgical Technique
Keywords
Guided biofilm terapy, Platelet Rich Fibrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided biofilm therapyDevice

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

  • Platelet Rich FibrinProcedure or surgery

    Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

  • Minimally Invasive Surgical TechniqueProcedure or surgery

    Periodontal intrabony defect is treated by minimally invasive surgical intervention

Study groups in NCT06768424
Study groupRoleWhat they receive
Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrineExperimentalNon surgical treatment performed to clean and decontaminate the intrabony defect, and filled with PRF
Receives: Device: Guided biofilm therapy; Procedure: Platelet Rich Fibrin
Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrineExperimentalSurgical procedure: Minimal invasive surical approach Platelet rich fibrine chops is used in order to fill the intrabony gap.
Receives: Procedure: Platelet Rich Fibrin; Procedure: Minimally Invasive Surgical Technique
Control groupActive comparatorThe control group patients are treated only with guided biofilm therapy alone
Receives: Device: Guided biofilm therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (3)

  1. PPD

    Pocket probing depth measured clinically by calibrated periodontal probe (UNC 15)

    Measured: 6 months

  2. GR

    Gingival recession measured clinically by calibrated periodontal probe (UNC 15)

    Measured: 6 months

  3. CAL

    Clinical attachment level measured clinically by calibrated periodontal probe (UNC 15)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start20 Dec 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768424
Sponsor's protocol ID
OGYÉI/55689-5/2023
Status last verified
Apr 2026
First submitted
10 Jul 2024
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33609186

  • 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.

    PubMed 28820322

  • 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.

    PubMed 27672729

  • 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.

    PubMed 35415940

Questions about this trial

What is this clinical trial studying?

A study testing Guided biofilm therapy, Platelet Rich Fibrin and Minimally Invasive Surgical Technique in people with Intrabony Periodontal Defect, run by Semmelweis University at 1 site in Hungary.

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 1 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 28 Apr 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 Hungary. 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 Pál Nagy, DMD (+3613185222, kardpali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrabony fill (time frame: 6 months). 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 NCT06768424, which also lists 4 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 28 Apr 2026.

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