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, Joint Research Office, (part of Research Support Center)
Clinicaltrials.gov Identifier
Z6364106/2022/07/113, UCL Data Protection Registration Number
Duration of Study in the UK
3 years, 6 months, days
Research summary
Dental and gum diseases are still very common in the UK and the damage caused by tooth extraction or gum disease is a matter of interest. Rebuilding gum and bone tissues after tooth removal is a critical point when planning to replace the tooth with either a bridge or dental implant. Our aim in this study to assess whether small grafts of gum tissues taken from a patient could be used to improve the gum and bone rebuilding after removing a tooth and prior to placing a dental implant.
In this study we wish to identify 44 participants who need a tooth removal (due to fracture or infection) and will need some bone gum and bone rebuilding. They will be allocated at random to either filling the tooth socket with a collagen plug only (control/standard of care) or a collagen plug with small gum grafts. A subset of participants (group A) will receive their dental implant after 6 weeks from the tooth removal whilst the rest (group B) will receive their dental implant at 12 weeks. This way we will be able to assess the bone healing at two different stages.
A series of clinical assessments (during and after removing the tooth) will be made alongside with a three-dimensional scan (CT scan), and non-invasive imaging (Optical Coherence Tomography, laser doppler and Ultrasound). Lastly the patients’ experience before and after the procedure with regards to discomfort and impact on their daily life will be recorded in all participants using validated questionnaires (Oral Impact on Daily Performance and Health Questionnaire EQ-5D-5L).REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0236
Date of REC Opinion
21 Mar 2023
REC opinion
Unfavourable Opinion