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

N/AActive Not RecruitingNCT06768424

Semmelweis University36 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Guided biofilm therapyDEVICE

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

Platelet Rich FibrinPROCEDURE

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

Minimally Invasive Surgical TechniquePROCEDURE

Periodontal intrabony defect is treated by minimally invasive surgical intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Semmelweis University Department of Periodontology

Budapest, Hungary

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

PPD

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

Time frame: 6 months

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

Time frame: 6 months

CAL

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

Time frame: 6 months

Data from ClinicalTrials.gov

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