Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

Not Applicable

Completed

• Conditions: Bone Regeneration; Dental Implants; Polytetrafluoroethylene
• Interventions: Procedure: Guided bone regeneration with a PTFE membrane; Procedure: Guided bone regeneration with a PTFE+collagen membrane

• Registration Number: NCT04843488
• Lead Sponsor: Urban Regeneration Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-13
• Study Start: 2021-04-15
• Primary Completion: 2022-11-12
• Study Completion: 2023-05-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridge Augmentation with a perforate PTFE mesh	Guided bone regeneration with a PTFE membrane	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.
Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane	Guided bone regeneration with a PTFE+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.

Primary Outcome Measures

Name	Time	Method
Bone gain	9 months	Vertical and horizontal bone gain measured
Complication rate	9 months	intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,

Trial Locations

Locations (1)

Urban Regeneration Institute; 🇭🇺 Budapest, Hungary