Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04843488

Enrollment

Registered

2021-04-13

Start date

2021-04-15

Completion date

2023-05-02

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Regeneration, Dental Implants, Polytetrafluoroethylene

Keywords

Guided Bone Regeneration, Vertical Ridge Regeneration, PTFE membrane

Brief summary

This randomized clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane. The primary endpoint is absolute vertical bone gain. The secondary endpoints are regeneration rate, complications rate, and pseudoperiosteum formation.

Interventions

PROCEDUREGuided bone regeneration with a PTFE membrane

Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws.

PROCEDUREGuided bone regeneration with a PTFE+collagen membrane

Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Partially edentulous patients requiring vertical and horizontal ridge augmentation 2. patients agrees with conditions of the study and sign consent

Exclusion criteria

* Insufficient oral hygiene * Smoking * Alcohol or Drug abuse * acute local or systemic infections * uncontrolled diabetes or other metabolic disease * severe hepatic or renal disfunction * autoimmune disease * radiotherapy in the last 5 years * patients receiving immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame	Description
Complication rate	9 months	intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,
Bone gain	9 months	Vertical and horizontal bone gain measured

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026