Alveolar Ridge DeficiencyNCT07520903

Titanium-Reinforced PTFE Membranes for Bone Augmentation

A study testing Titanium-reinforced dense PTFE membrane (TiR-dPTFE) and Reinforced PTFE mesh (RPM) in people with Alveolar Ridge Deficiency and Alveolar Bone Loss, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Alveolar Ridge Deficiency, Alveolar Bone Loss, Jaw Atrophy
What is being tested?: Titanium-reinforced dense PTFE membrane (TiR-dPTFE) and Reinforced PTFE mesh (RPM)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 sitePortugal
Study dates: 1 Apr 2022to 1 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

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

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Conditions: Alveolar Ridge Deficiency, Alveolar Bone Loss, Jaw Atrophy
Being tested: Titanium-reinforced dense PTFE membrane (TiR-dPTFE), Reinforced PTFE mesh (RPM)
Keywords: Guided bone regeneration, Vertical ridge augmentation, Horizontal ridge augmentation, Titanium-reinforced PTFE membrane, PTFE mesh, Barrier membranes, Dental implant site development, CBCT bone augmentation assessment
Medical subject headings: Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Titanium-reinforced dense PTFE membrane (TiR-dPTFE)Device
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.
Reinforced PTFE mesh (RPM)Device
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.

Study groups in NCT07520903
Study group	Role	What they receive
TiR-dPTFE membrane	Experimental	Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture. Receives: Device: Titanium-reinforced dense PTFE membrane (TiR-dPTFE)
Reinforced PTFE mesh (RPM)	Experimental	Guided bone regeneration using reinforced PTFE mesh with autogenous bone and xenograft mixture. Receives: Device: Reinforced PTFE mesh (RPM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Vertical Bone Gain (VBG)
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.
Measured: 9 months and 12 months after guided bone regeneration surgery

Secondary outcomes (3)

Horizontal Bone Gain (HBG)
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.
Measured: 9 months and 12 months after guided bone regeneration surgery
Postoperative Healing Complications
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.
Measured: From surgery to 12 months after guided bone regeneration
Histological Characteristics of Regenerated Bone
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.
Measured: 9 months after guided bone regeneration surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20221 Jun 2024

First posted9 Apr 2026
Study start1 Apr 2022
Primary completion1 Jun 2024
Study completion1 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Alveolar Ridge DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Prospective non-randomized comparative case series evaluating guided bone regeneration for vertical and horizontal ridge augmentation prior to implant placement. Participants were assigned to treatment with titanium-reinforced dense PTFE membranes or reinforced PTFE mesh according to clinical indication and defect characteristics within a standardized surgical protocol.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07520903
Sponsor's protocol ID: 5/2022 FMDUP
Status last verified: Apr 2026
First submitted: 2 Apr 2026
Last updated: 9 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Publications

Urban IA, Saleh MHA, Ravida A, Forster A, Wang HL, Barath Z. Vertical bone augmentation utilizing a titanium-reinforced PTFE mesh: A multi-variate analysis of influencing factors. Clin Oral Implants Res. 2021 Jul;32(7):828-839. doi: 10.1111/clr.13755. Epub 2021 Apr 24.
PubMed 33786888
Cucchi A, Vignudelli E, Napolitano A, Marchetti C, Corinaldesi G. Evaluation of complication rates and vertical bone gain after guided bone regeneration with non-resorbable membranes versus titanium meshes and resorbable membranes. A randomized clinical trial. Clin Implant Dent Relat Res. 2017 Oct;19(5):821-832. doi: 10.1111/cid.12520. Epub 2017 Jul 26.
PubMed 28745035
Soldatos N, Garcia M, Umoh E, Irizarry A, Weltman R. Vertical Ridge Augmentation Around Dental Implants With the Use of a Dense PTFE Membrane to Correct Previously Failed Augmentations. Clin Adv Periodontics. 2022 Mar;12(1):51-56. doi: 10.1002/cap.10182. Epub 2021 Oct 13.
PubMed 34553846
Urban IA, Lozada JL, Jovanovic SA, Nagursky H, Nagy K. Vertical ridge augmentation with titanium-reinforced, dense-PTFE membranes and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 19 patients. Int J Oral Maxillofac Implants. 2014 Jan-Feb;29(1):185-93. doi: 10.11607/jomi.3346.
PubMed 24451870

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Not yet recruiting
Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement
Horizontally Deficient Alveolar Ridges, Hard and Soft Tissue Augmentation During Delayed Implant Placement

All Alveolar Ridge Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vertical and Horizontal Ridge Augmentation With Titanium-Reinforced Dense PTFE Versus Reinforced PTFE Mesh: A Prospective Comparative Case Series
ClinicalTrials.gov ID: NCT07520903
Acronym / sponsor ID: 5/2022 FMDUP
Conditions: Alveolar Ridge Deficiency, Alveolar Bone Loss, Jaw Atrophy
Keywords: Guided bone regeneration, Vertical ridge augmentation, Horizontal ridge augmentation, Titanium-reinforced PTFE membrane, PTFE mesh, Barrier membranes, Dental implant site development, CBCT bone augmentation assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Universidade do PortoUniversity, hospital or other
Study start: 1 Apr 2022 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 9 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective non-randomized comparative case series evaluating guided bone regeneration for vertical and horizontal ridge augmentation prior to implant placement. Participants were assigned to treatment with titanium-reinforced dense PTFE membranes or reinforced PTFE mesh according to clinical indication and defect characteristics within a standardized surgical protocol.

Arm	Type	Receives
TiR-dPTFE membrane	Experimental	Device: Titanium-reinforced dense PTFE membrane (TiR-dPTFE)Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture.
Reinforced PTFE mesh (RPM)	Experimental	Device: Reinforced PTFE mesh (RPM)Guided bone regeneration using reinforced PTFE mesh with autogenous bone and xenograft mixture.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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%

Key exclusion criteria (7 listed)

History of radiotherapy in the head and neck region
Smoking
Alcoholism or substance abuse
Untreated or active periodontitis
Pregnancy or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	TiR-dPTFE membrane
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.	Device	Reinforced PTFE mesh (RPM)

Primary outcome

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.

3 secondary outcomes

Horizontal Bone Gain (HBG)
Time frame: 9 months and 12 months after guided bone regeneration surgery
Postoperative Healing Complications
Time frame: From surgery to 12 months after guided bone regeneration
Histological Characteristics of Regenerated Bone
Time frame: 9 months after guided bone regeneration surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Background: PubMed 33786888Urban IA, Saleh MHA, Ravida A, Forster A, Wang HL, Barath Z. Vertical bone augmentation utilizing a titanium-reinforced PTFE mesh: A multi-variate analysis of influencing factors. Clin Oral Implants Res. 2021 Jul;32(7):828-839. doi: 10.1111/clr.13755. Epub 2021 Apr 24.
Background: PubMed 28745035Cucchi A, Vignudelli E, Napolitano A, Marchetti C, Corinaldesi G. Evaluation of complication rates and vertical bone gain after guided bone regeneration with non-resorbable membranes versus titanium meshes and resorbable membranes. A randomized clinical trial. Clin Implant Dent Relat Res. 2017 Oct;19(5):821-832. doi: 10.1111/cid.12520. Epub 2017 Jul 26.
Background: PubMed 34553846Soldatos N, Garcia M, Umoh E, Irizarry A, Weltman R. Vertical Ridge Augmentation Around Dental Implants With the Use of a Dense PTFE Membrane to Correct Previously Failed Augmentations. Clin Adv Periodontics. 2022 Mar;12(1):51-56. doi: 10.1002/cap.10182. Epub 2021 Oct 13.
Background: PubMed 24451870Urban IA, Lozada JL, Jovanovic SA, Nagursky H, Nagy K. Vertical ridge augmentation with titanium-reinforced, dense-PTFE membranes and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 19 patients. Int J Oral Maxillofac Implants. 2014 Jan-Feb;29(1):185-93. doi: 10.11607/jomi.3346.
Individual participant dataSharing planned: Undecided. 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.

Related trials for Alveolar Ridge Deficiency

Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Not yet recruiting
Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement
Horizontally Deficient Alveolar Ridges, Hard and Soft Tissue Augmentation During Delayed Implant Placement

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical Bone Gain (VBG) (time frame: 9 months and 12 months after guided bone regeneration surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520903, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.