VARGAS
Research type
Research Study
Full title
Vertical Ridge Augmentation Strategies. An Adaptive Randomised Controlled Clinical Trial
IRAS ID
297914
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
University College London Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Z6364106/2021/09/64, UCL Data Protection Registration
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Vertical bone augmentation (VRA) represents one of the most challenging bone regenerative procedures in surgical dentistry. This is because of the inherent difficulties of the surgical procedure and the high risk of complications. The primary aim of this procedure is to recreate alveolar bone in a vertical direction (without the support of any pre-existing walls) and enable recreation of a more favourable anatomy for the restoration of the edentulous site with dental implants.
Guided Bone Regeneration (GBR) is a surgical technique adopted when there is the need for vertical bone augmentation. Nowadays, in 2021, the “state of the art” in GBR procedures is the use of barrier membranes to contain bone substitute biomaterials and/or autogenous bone chips to recreate new alveolar bone.
The existing limited evidence supporting the use of VRA encompasses few clinical trials which suffer from many weaknesses. Therefore, the aim of this study is to assess and compare incidence of complications and percentage of vertical bone gain when using four different barrier membranes in combination with 50/50 autogenous and xenogenous bone material in VRA procedures.
The study will involve two centres and will recruit 148 participants which will enter a randomised controlled trial. Participants enrolled in the study will be randomly assigned to tests or control groups. Participants will attend a total of 18 visits during their enrollment in the study. The first two visits will be intended for screening and baseline assessments, respectively. In the third visit, each participant will undergo VRA surgery according to the allocated group. Implant placement for all participants will take place in the eighth visit which will be at 180 days after VRA surgery. Prosthetic (external) component of the implant will placed at 120 days after implant placement. All participant will have 7 follow-up visits after VRA and after implant placement.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0501
Date of REC Opinion
2 Sep 2022
REC opinion
Further Information Favourable Opinion