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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TiR-dPTFE membrane | Experimental | Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture. |
|
| Reinforced PTFE mesh (RPM) | Experimental | Guided bone regeneration using reinforced PTFE mesh with autogenous bone and xenograft mixture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months and 12 months after guided bone regeneration surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine, University of Porto | Porto | Porto District | 4200-393 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33786888 | Background | 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. | |
| 28745035 | 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. |
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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.
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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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.
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| 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. |
|
| 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. | 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. | 9 months after guided bone regeneration surgery |
| 34553846 | 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. |
| 24451870 | 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. |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |