Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation
Study Details
Study Description
Brief Summary
This randomized clinical trial (RCT) study investigates if there is any difference in complication rate between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane.
The primary endpoint is complication rate. The secondary endpoints are regeneration rate and pseudoperiosteum formation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ridge Augmentation with a perforate PTFE mesh Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The graft material is autograft mixed with a xenograft in a 1:1 ratio. |
Procedure: Guided bone regeneration with a PTFE membrane
Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws.
|
| Experimental: Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The mesh will be covered with a native collagen membrane. The graft material is autograft mixed with a xenograft in a 1:1 ratio. |
Procedure: Guided bone regeneration with a PTFE+collagen membrane
Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently.
|
Outcome Measures
Primary Outcome Measures
- Complication rate [9 months]
intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,
- Bone gain [9 months]
Vertical and horizontal bone gain measured
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Partially edentulous patients requiring vertical and horizontal ridge augmentation
-
patients agrees with conditions of the study and sign consent
Exclusion Criteria:
-
Insufficient oral hygiene
-
Smoking
-
Alcohol or Drug abuse
-
acute local or systemic infections
-
uncontrolled diabetes or other metabolic disease
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severe hepatic or renal disfunction
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autoimmune disease
-
radiotherapy in the last 5 years
-
patients receiving immunosuppressive therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urban Regeneration Institute | Budapest | Hungary | 1025 |
Sponsors and Collaborators
- Urban Regeneration Institute
- Szeged University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Plonka AB, Urban IA, Wang HL. Decision Tree for Vertical Ridge Augmentation. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):269-275. doi: 10.11607/prd.3280. Review.
- Urban IA, Monje A, Lozada J, Wang HL. Principles for Vertical Ridge Augmentation in the Atrophic Posterior Mandible: A Technical Review. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):639-645. doi: 10.11607/prd.3200. Review.
- Urban IA, Monje A, Lozada JL, Wang HL. Long-term Evaluation of Peri-implant Bone Level after Reconstruction of Severely Atrophic Edentulous Maxilla via Vertical and Horizontal Guided Bone Regeneration in Combination with Sinus Augmentation: A Case Series with 1 to 15 Years of Loading. Clin Implant Dent Relat Res. 2017 Feb;19(1):46-55. doi: 10.1111/cid.12431. Epub 2016 May 30.
- Urban IA, Monje A, Nevins M, Nevins ML, Lozada JL, Wang HL. Surgical Management of Significant Maxillary Anterior Vertical Ridge Defects. Int J Periodontics Restorative Dent. 2016 May-Jun;36(3):329-37. doi: 10.11607/prd.2644.
- Urban IA, Montero E, Monje A, Sanz-Sánchez I. Effectiveness of vertical ridge augmentation interventions: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:319-339. doi: 10.1111/jcpe.13061.
- PTFE1