Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

Urban Regeneration Institute

Status: Completed

Conditions: Dental Implants; Polytetrafluoroethylene; Bone Regeneration

Treatments: Procedure: Guided bone regeneration with a PTFE membrane; Procedure: Guided bone regeneration with a PTFE+collagen membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT04843488

PTFE1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Ridge Augmentation with a perforate PTFE mesh

Active Comparator group

Description:

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.

Treatment:

Procedure: Guided bone regeneration with a PTFE membrane

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

Experimental group

Description:

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.

Treatment:

Procedure: Guided bone regeneration with a PTFE+collagen membrane