Titanium-Reinforced PTFE Membranes for Bone Augmentation

Universidade do Porto

Status

Completed

Conditions

Jaw Atrophy

Alveolar Ridge Deficiency

Alveolar Bone Loss

Treatments

Device: Reinforced PTFE mesh (RPM)

Device: Titanium-reinforced dense PTFE membrane (TiR-dPTFE)

Study type

Interventional

Funder types

Other

Identifiers

NCT07520903

5/2022 FMDUP

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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