Guided Bone Regeneration Clinical Trial
— SSBS for ABAOfficial title:
Evaluation of Clinical Outcomes of the Semi-rigid Shell Barrier System for Alveolar Bone Augmentation
This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | June 30, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth - Planned for dental implant and fixed prosthesis - Aged 20 and above but under the age of 65 with good physical health and good oral hygiene - Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment. - Available for follow-up after implant placement. Exclusion Criteria: - (i) Heavy smokers (>10 cigarettes/day) - (ii) receiving bisphosphonates - (iii) undergoing radiotherapy - (iv) uncontrolled medical conditions - (v) Alcoholism - (vi) Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Thailand | Prince of Songkla | Songkhla | Hatyai |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone gain evaluation | CBCT images will be taken of the alveolar bone defect with an acrylic stent before the operation as a baseline, immediately post-operative, and 4 months after the operation. The most obvious point of the marker will be used to determine the vertical and horizontal bone gain.The distances from the reference points to the alveolar bone defect will be measured using analysis software.Any changes in the distances between the time points will be calculated in percentages. | 4 months | |
Primary | Biocompatibility evaluation | The semi-resorbable covering membrane and the semi-rigid shell will be removed during the re-entry visit, and a trephine bone in size of 2x4 mm. will be analyzed using standard histology. The specimen will be fixed with 10% formalin, then the specimens will be embedded in paraffin, and longitudinal serial 5 µm-thick sections will be cut through their midline and stained with Hematoxylin and Eosin (H&E). The section slides will be scanned using a slide scanner (ScanScope, Aperio, USA) to create image files. The histological features of the specimens will be evaluated descriptively. | 4 months | |
Secondary | Ridge volume change of alveolar ridge evaluation | The study will measure and analyze the volume change of the buccal alveolar ridge at baseline, 1 month, and 4 months after a bone augmentation procedure. The images will be obtained using an intraoral scanner and exported as stereolithography (STL) files. To minimize image distortion, matching and superimposition of 3D models of preoperative and postoperative bone defects will be conducted. The analysis of the data will be done using Geomagic Studio 1 software.The region of interest will be designated 10 mm. below the bone peak of adjacent teeth, and the volume of soft tissue in the targeted area will be calculated. The clinical ridge volume of bone defects will be measured in cubic mm. (mm.3) using a volumetric analysis tool. | 4 months |
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