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OpenTrials
Completed

NCT Number: NCT04843488

Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation

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.

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Key information

Conditions

Bone Regeneration Dental Implants Polytetrafluoroethylene

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urban Regeneration Institute

Budapest, 1025, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Partially edentulous patients requiring vertical and horizontal ridge augmentation
  • 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

Treatment and study plan

Guided bone regeneration with a PTFE membrane

Procedure

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.

Guided bone regeneration with a PTFE+collagen membrane

Procedure

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.

Primary outcomes

  1. Complication rate

    Time frame: 9 months

    intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,

  2. Bone gain

    Time frame: 9 months

    Vertical and horizontal bone gain measured

Sponsors and collaborators

Lead sponsor

Urban Regeneration Institute

Other

Collaborators

  • Szeged University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 13, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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