Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

Dental Implants Clinical Trial

Official title:

Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843488
• Other study ID #: PTFE1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: September 2023
• Source: Urban Regeneration Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2, 2023
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Regeneration
• Dental Implants
• Polytetrafluoroethylene

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hungary	Urban Regeneration Institute	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Urban Regeneration Institute	Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,	9 months
Primary	Bone gain	Vertical and horizontal bone gain measured	9 months