Clinical trial NCT06768424: Comparison of MIST With PRF and GBT With PRF in the Treatment of Intrabony Periodontal Defect. A Prospective RCT
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: Guided biofilm terapy
Platelet Rich Fibrine
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intrabony fill
timeFrame: 6 months
Secondary outcomes:
measure: PPD
timeFrame: 6 months
measure: GR
timeFrame: 6 months
measure: CAL
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.