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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
| Institut Straumann AG | INDUSTRY |
| Dicomlab Kft. | UNKNOWN |
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The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.
The aim of our study was to compare the clinical, radiological, circulatory, and histological studies of a novel, split-thickness and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation surgeries. Flap formation was performed in the test group using the novel split-thickness surgical technique, and in the control group using the full-thickness mucoperostatial surgical technique. The novel split-thickness flap technique to be studied results in a predictable, closed healing based on our preliminary results, thus ensuring the conditions for successful augmentation. We primarily want to investigate what hard and soft tissue changes result from ridge augmentation with a novel split-thickness flap technique after 6 months, compared to a surgical technique based on full thick flap formation accepted as a standard procedure in the literature. Our secondary examination methods: examination of early wound healing and micro-circulation after augmentation interventions by LSCI method; histological evaluation at prosthetically designed implant positions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-thickness group | Experimental | Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. |
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| Full-thickness group | Experimental | Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split-thickness group | Procedure | Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Orovestibular ridge width | On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of the surgical area. | 6 months postoperatively |
| Dimensional change of keratinized Gingiva | Pre-and postoperatively a surface scan is performed using a Planmeca Emerald intraroral scanner. The superimposition of the measurements was used to evaluate the soft tissue changes associated with the treatments in 3 dimension. | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Histomorphometrical analysis | Percentage of newly formed bone, bone substitute and connective tissue | Following reentry 6 months after augmentation |
| Gingival blood flow measurement at the early wound healing phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bálint Molnár, DMD, PhD | Contact | 0036302553334 | molbal81@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Department of Periodontology | Recruiting | Budapest | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39342334 | Derived | Somodi K, Dobos A, Bartha F, Solyom E, Windisch P, Palkovics D, Molnar B. Changes in soft tissue dimensions following horizontal guided bone regeneration with a split-thickness flap design - evaluation of 8 cases with a digital method. Head Face Med. 2024 Sep 28;20(1):53. doi: 10.1186/s13005-024-00456-8. |
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Test group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
Control group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
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Participants are not aware of the randomly assigned flap design. Independent examiners are not aware of patient allocation during analysis of clinical and radiographic data.
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| Full-thickness group | Procedure | Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. |
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Investigation of pre- and postoperative gingival blood flow using Laser Speckle Contrast Imager.
| Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries. |