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

Semmelweis University

Status: Active, not recruiting

Conditions: Intrabony Periodontal Defect

Treatments: Device: Guided biofilm therapy; Procedure: Platelet Rich Fibrin; Procedure: Minimally Invasive Surgical Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06768424

OGYÉI/55689-5/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine

Experimental group

Description:

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

Treatment:

Procedure: Platelet Rich Fibrin

Device: Guided biofilm therapy

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

Experimental group

Description:

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

Treatment:

Procedure: Minimally Invasive Surgical Technique

Procedure: Platelet Rich Fibrin

Control group

Active Comparator group

Description:

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

Treatment:

Device: Guided biofilm therapy