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

NCT ID: NCT06768424

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-12-20

Brief 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.

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.

Conditions

Intrabony Periodontal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Guided biofilm therapy

Intervention Type: DEVICE

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

Platelet Rich Fibrin

Intervention Type: PROCEDURE

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

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.

Group Type: EXPERIMENTAL

Platelet Rich Fibrin

Intervention Type: PROCEDURE

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

Minimally Invasive Surgical Technique

Intervention Type: PROCEDURE

Periodontal intrabony defect is treated by minimally invasive surgical intervention

Control group

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

Group Type: ACTIVE_COMPARATOR

Guided biofilm therapy

Intervention Type: DEVICE

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

Interventions

Guided biofilm therapy

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

Intervention Type: DEVICE

Platelet Rich Fibrin

Pack Platelet Rich Fibrin chops into the intrabony periodontla defect

Intervention Type: PROCEDURE

Minimally Invasive Surgical Technique

Periodontal intrabony defect is treated by minimally invasive surgical intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Pal Nagy

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Semmelweis University Department of Periodontology

Budapest, , Hungary

Countries

Hungary

References

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.

Reference Type: BACKGROUND

PMID: 33609186 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28820322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27672729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35415940 (View on PubMed)

Other Identifiers

OGYÉI/55689-5/2023

Identifier Type: -

Identifier Source: org_study_id