NCT07520903

Titanium-Reinforced PTFE Membranes for Bone Augmentation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Portugal