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NCT Number: NCT06768424

Comparison of MIST With PRF and GBT With PRF in the Treatment of 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

Location status: Recruiting

Location contact

Pal Nagy, DMD

CONTACT

[email protected]

+3613185222

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Biofilm Therapy

Device

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

Platelet Rich Fibrin

Procedure

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

minimally invasive surgical technique

Procedure

Periodontal intrabony defect is treated by minimally invasive surgical intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. PPD

    Time frame: 6 months

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

  2. GR

    Time frame: 6 months

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

  3. CAL

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pál Nagy, DMD

CONTACT

[email protected]

+3613185222

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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