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Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

U

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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