Titanium-Reinforced PTFE Membranes for Bone Augmentation

NCT07520903 | Completed

• 1 other identifier: 5/2022 FMDUP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months and 12 months after guided bone regeneration surgery

Secondary Outcomes (3)

• Horizontal Bone Gain (HBG)

  9 months and 12 months after guided bone regeneration surgery

• Postoperative Healing Complications

  From surgery to 12 months after guided bone regeneration

• Histological Characteristics of Regenerated Bone

  9 months after guided bone regeneration surgery

Study Arms (2)

TiR-dPTFE membrane

EXPERIMENTAL

Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture.

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.

Device: Reinforced PTFE mesh (RPM)

Interventions

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.

Reinforced PTFE mesh (RPM)

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.

TiR-dPTFE membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Dental Medicine, University of Porto

Porto, Porto District, 4200-393, Portugal

Location

Related Publications (4)

• 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.

  PMID: 33786888 BACKGROUND

• 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.

  PMID: 28745035 BACKGROUND

• 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.

  PMID: 34553846 BACKGROUND

• 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.

  PMID: 24451870 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

PT (1)