Tissue Engineering for Soft Tissue Augmentation in Periodontal Surgery
Research type
Research Study
Full title
Tissue Engineering and Soft Tissue Augmentation Procedures : A Randomized Controlled Clinical Trials
IRAS ID
287761
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
University College London, Joint Research Office, (part of Research Support Centre)
Clinicaltrials.gov Identifier
Z634106/2021/10/19 clinical research, Data Protection Number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Combined the tissue engineering and periodontal tissue augmentation procedures reveal that the advancement in soft tissue substitutes materials give a chance to achieve the gold standard quality of mucogingival surgery. This is a single-centre, non-inferiority, assessor-blind clinical trial, with balanced randomization and four parallel groups with efficient adaptive design in comparing different materials and cell-based tissue engineering in managing soft tissue deficiencies around natural teeth patients. All study participants should assign the informed consent, and all study procedures were performed according to the Declaration of Helsinki on experimentation involving human subjects.
The purpose of the study will be to assess the clinical composite outcome measurement (keratinized tissue width and percentage of complete root coverage) of soft tissue augmentation procedures in natural teeth, using xenograft cross-linked collagen materials alone or combined with cell-based engineering techniques as valid alternatives to autologous tissues in mucogingival therapy. This topic was identified as being of importance to obtain a better soft tissue substitutes biomaterial that required a clinical impact that nearly equal to the gold standard, moreover, bringing the better aesthetic result and comfort for the patients.
REC name
North West - Preston Research Ethics Committee
REC reference
22/NW/0347
Date of REC Opinion
6 Jan 2023
REC opinion
Further Information Favourable Opinion