Comparison of MIST With PRF and GBT With PRF in the Treatment of Intrabony Periodontal Defect. A Prospective RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guided biofilm therapy, Platelet Rich Fibrin, Minimally Invasive Surgical Technique.
- Who it may be relevant to
- Registry conditions: Intrabony Periodontal Defect. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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.
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.
Interventions
- Device Guided biofilm therapy
Use of Airflow Plus powder subgingivally on teeth with deep periodeontal pockets - Procedure Platelet Rich Fibrin
Pack Platelet Rich Fibrin chops into the intrabony periodontla defect - Procedure Minimally Invasive Surgical Technique
Periodontal intrabony defect is treated by minimally invasive surgical intervention
Primary outcome measures
- Intrabony fill [Time frame: 6 months]
Secondary outcome measures (3)
- PPD [Time frame: 6 months]
- GR [Time frame: 6 months]
- CAL [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Semmelweis University Department of Periodontology — Budapest
Publications
- 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. PMID 33609186
- 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. PMID 28820322
- 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. PMID 27672729
- 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. PMID 35415940
Identifiers
NCT: NCT06768424 · OGYÉI/55689-5/2023