Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

NCT04843488 | Completed

• 1 other identifier: PTFE1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Regeneration; Dental Implants; Polytetrafluoroethylene

Keywords

Guided Bone Regeneration; Vertical Ridge Regeneration; PTFE membrane

Outcome Measures

Primary Outcomes (2)

• Complication rate

  intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,

  9 months

• Bone gain

  Vertical and horizontal bone gain measured

  9 months

Study Arms (2)

Ridge Augmentation with a perforate PTFE mesh

ACTIVE COMPARATOR

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

Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane

EXPERIMENTAL

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

Interventions

Guided bone regeneration with a PTFE membrane PROCEDURE

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.

Ridge Augmentation with a perforate PTFE mesh

Guided bone regeneration with a PTFE+collagen membrane PROCEDURE

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.

Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially edentulous patients requiring vertical and horizontal ridge augmentation
• patients agrees with conditions of the study and sign consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Urban Regeneration Institute: lead
• Szeged University: collaborator

Study Sites (1)

Urban Regeneration Institute

Budapest, 1025, Hungary

Location

Related Publications (6)

• 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.

  PMID: 30667522 BACKGROUND

• 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.

  PMID: 28817126 BACKGROUND

• 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.

  PMID: 29447321 BACKGROUND

• 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.

  PMID: 27238406 BACKGROUND

• 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.

  PMID: 27100802 BACKGROUND

• Urban IA, Serroni M, Dias DR, Barath Z, Forster A, Araujo TG, Saleh MHA, Cucchi A, Ravida A. Impact of Collagen Membrane in Vertical Ridge Augmentation Using Ti-Reinforced PTFE Mesh: A Randomised Controlled Trial. J Clin Periodontol. 2025 Apr;52(4):575-588. doi: 10.1111/jcpe.14129. Epub 2025 Feb 14.

  PMID: 39953742 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: April 15, 2021
• Primary Completion: November 12, 2022
• Study Completion: May 2, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)