Clinical trial NCT04843488: Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation
Official title: Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Regeneration
Dental Implants
Polytetrafluoroethylene
Keywords: Guided Bone Regeneration
Vertical Ridge Regeneration
PTFE membrane
Lead sponsor: Urban Regeneration Institute
Sponsor class: OTHER
Collaborators: name: Szeged University
First posted: 2021-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane.

The primary endpoint is absolute vertical bone gain. The secondary endpoints are regeneration rate, complications rate, and pseudoperiosteum formation.


Eligibility criteria: Inclusion Criteria:

1. Partially edentulous patients requiring vertical and horizontal ridge augmentation
2. 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
* severe hepatic or renal disfunction
* autoimmune disease
* radiotherapy in the last 5 years
* patients receiving immunosuppressive therapy

Primary outcomes:
measure: Complication rate
timeFrame: 9 months
measure: Bone gain
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Urban Regeneration Institute
Study officials:
References:
citation: Urban IA, Montero E, Monje A, Sanz-Sanchez 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.