Regenerative Therapies for Alveolar Ridge (RIGENERO)
Research type
Research Study
Full title
Regenerative Potential of Tissue Specific Cell-Based Therapies for Alveolar Ridge Preservation. A Randomised Controlled Clinical Trial
IRAS ID
314080
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2022/07/113, UCL Data Protection Registration Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of this study is to find out the benefit of using micrografts for gum and bone rebuilding after tooth removal in 60 participants randomly divided into two groups. The first group will receive a collagen plug (control) while the second group will receive a collagen plug with small gum grafts (test). Micro-grafts obtained using the Rigeneracons® device have shown to promote bone formation and repair. The device has been used to collect small tissue samples from various sites in the body including gum tissue from the roof of the mouth.
A series of exams will be planned before and after the tooth removal procedure. The main outcome of the study is to
compare the volume of bone and gum tissue formed in each group. For this we shall take three-dimensional scans
(CT scan) of the bone/gums, along with Optical Coherence Tomography, laser doppler, and Ultrasound (all non
invasive devices). Further we shall record participants' experiences before and after the procedure regarding pain and impact on their daily life using validated questionnaires, including the Oral Impact on Daily Performance and Health Questionnaire EQ-5D-5L.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0034
Date of REC Opinion
22 Apr 2024
REC opinion
Further Information Favourable Opinion