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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 Guided biofilm therapy in combinaton with Platelet rich fibrine | Experimental | Non surgical treatment performed to clean and decontaminate the intrabony defect, and filled with PRF |
|
| Test 2 Minimally invasive surgical therapy in combination with Platelet rich fibrine | Experimental | Surgical procedure: Minimal invasive surical approach Platelet rich fibrine chops is used in order to fill the intrabony gap. |
|
| Control group | Active Comparator | The control group patients are treated only with guided biofilm therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided biofilm therapy | Device | Use of Airflow Plus powder subgingivally on teeth with deep periodeontal pockets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PPD | Pocket probing depth measured clinically by calibrated periodontal probe (UNC 15) | 6 months |
| GR | Gingival recession measured clinically by calibrated periodontal probe (UNC 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pál Nagy, DMD | Contact | +3613185222 | kardpali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Department of Periodontology | Recruiting | Budapest | Budapest | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33609186 | Background | 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. | |
| 28820322 |
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| Platelet Rich Fibrin | Procedure | Pack Platelet Rich Fibrin chops into the intrabony periodontla defect |
|
| Minimally Invasive Surgical Technique | Procedure | Periodontal intrabony defect is treated by minimally invasive surgical intervention |
|
| 6 months |
| CAL | Clinical attachment level measured clinically by calibrated periodontal probe (UNC 15) | 6 months |
| Background |
| 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. |
| 27672729 | Background | 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. |
| 35415940 | Background | 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. |