Titanium-Reinforced PTFE Membranes for Bone Augmentation

April 2, 2026 updated by: Universidade do Porto

Vertical and Horizontal Ridge Augmentation With Titanium-Reinforced Dense PTFE Versus Reinforced PTFE Mesh: A Prospective Comparative Case Series

This prospective comparative clinical study evaluated vertical and horizontal bone gain after guided bone regeneration using titanium-reinforced dense PTFE (TiR-dPTFE) membranes versus reinforced PTFE mesh (RPM) in patients requiring ridge augmentation prior to implant placement. Radiographic outcomes were assessed using CBCT at baseline, 9 months, and 12 months. Histological evaluation was performed in selected cases. Healing events and complications were recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective comparative case series investigated the clinical and radiographic performance of two non-resorbable barrier membranes used for guided bone regeneration (GBR): titanium-reinforced dense PTFE (TiR-dPTFE) and reinforced PTFE mesh (RPM).

Fourteen patients presenting alveolar ridge defects requiring vertical and/or horizontal augmentation prior to implant placement were consecutively enrolled. A total of 46 defect sites were treated using autogenous bone mixed with anorganic bovine bone mineral and covered with either TiR-dPTFE or RPM membranes.

Vertical bone gain (VBG) and horizontal bone gain (HBG) were measured on standardized CBCT cross-sections at baseline, 9 months, and 12 months. Histological evaluation of regenerated bone was performed in selected cases at re-entry. Adverse events and healing outcomes were recorded throughout follow-up.

The study aimed to compare dimensional bone regeneration outcomes and safety between the two GBR approaches.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4200-393
        • Faculty of Dental Medicine, University of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Partial or total edentulism requiring guided bone regeneration prior to implant placement
  • Presence of vertical alveolar bone defect >3 mm
  • Full-mouth plaque score <10%
  • Full-mouth bleeding on probing score <10%
  • Ability to understand study procedures and provide written informed consent
  • Provision of written informed consent prior to enrollment

Exclusion Criteria:

  • History of radiotherapy in the head and neck region
  • Smoking
  • Alcoholism or substance abuse
  • Untreated or active periodontitis
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the previous 30 days
  • Medical or behavioral conditions that could interfere with study participation or outcome evaluation, including poor compliance or unreliability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TiR-dPTFE membrane
Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture.
Device: Titanium-reinforced dense PTFE membrane (TiR-dPTFE)
Guided bone regeneration (GBR) surgery for vertical and/or horizontal ridge augmentation prior to implant placement using a titanium-reinforced dense polytetrafluoroethylene membrane (TiR-dPTFE) to stabilize a particulate graft composed of autogenous bone chips and anorganic bovine bone mineral (60:40 ratio). The membrane was adapted to the defect morphology, stabilized with titanium fixation pins, and covered with a resorbable collagen membrane before tension-free primary closure. After 9 months, membrane removal and implant placement were performed with secondary protective augmentation (70:30 ABBM/autogenous). Allocation followed a prospective comparative protocol based on clinical indication.
Experimental: Reinforced PTFE mesh (RPM)
Guided bone regeneration using reinforced PTFE mesh with autogenous bone and xenograft mixture.
Device: Reinforced PTFE mesh (RPM)
Guided bone regeneration (GBR) surgery for vertical and/or horizontal ridge augmentation prior to implant placement using a reinforced PTFE mesh (RPM) to stabilize a particulate graft composed of autogenous bone chips and anorganic bovine bone mineral (60:40 ratio). The membrane was adapted to the defect morphology, stabilized with titanium fixation pins, and covered with a resorbable collagen membrane before tension-free primary closure. After 9 months, membrane removal and implant placement were performed with secondary protective augmentation (70:30 ABBM/autogenous). Allocation followed a prospective comparative protocol based on clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Bone Gain (VBG)
Time Frame: 9 months and 12 months after guided bone regeneration surgery

Vertical bone gain (mm) measured using standardized cone beam computed tomography (CBCT) cross-sectional images by comparing baseline measurements before guided bone regeneration with measurements obtained at follow-up. Measurements were performed using matched anatomical landmarks and calibrated digital image analysis software.

Measurements were performed at the implant-site level with clustering within participants considered during statistical analysis.
9 months and 12 months after guided bone regeneration surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal Bone Gain (HBG)
Time Frame: 9 months and 12 months after guided bone regeneration surgery
Horizontal bone gain (mm) measured using standardized cone beam computed tomography (CBCT) cross-sectional images by comparing baseline ridge width measurements before guided bone regeneration with follow-up measurements obtained at 9 and 12 months using calibrated digital image analysis.
9 months and 12 months after guided bone regeneration surgery
Postoperative Healing Complications
Time Frame: From surgery to 12 months after guided bone regeneration
Incidence of postoperative complications including membrane exposure, infection, wound dehiscence, or need for additional surgical intervention recorded during the healing period following guided bone regeneration.
From surgery to 12 months after guided bone regeneration
Histological Characteristics of Regenerated Bone
Time Frame: 9 months after guided bone regeneration surgery
Qualitative histological assessment of regenerated bone tissue obtained from core biopsies at re-entry surgery to evaluate bone vitality, graft integration, lamellar structure, and absence of inflammatory or necrotic tissue in selected cases.
9 months after guided bone regeneration surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2022 FMDUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A final decision regarding sharing of individual participant data has not yet been made. Data sharing will be considered following institutional policies, ethics committee guidance, and applicable data protection regulations. De-identified datasets may be made available upon reasonable request after completion of the study and publication of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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