Titanium-Reinforced PTFE Membranes for Bone Augmentation

N/ACompletedNCT07520903

Universidade do Porto14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Ridge Deficiency Alveolar Bone Loss Jaw Atrophy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dental Medicine, University of Porto

Porto, Porto District, Portugal

Outcomes

Primary Outcomes

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.

Time frame: 9 months and 12 months after guided bone regeneration surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 9 months after guided bone regeneration surgery

Data from ClinicalTrials.gov

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