Hyaluronic acid and polynucleotides for supra-bony defects
Research type
Research Study
Full title
Characterizing the healing of periodontal supra-bony defects treated with hyaluronic acid and polynucleotides
IRAS ID
339479
Contact name
Elena Calciolari
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 3 days
Research summary
Supra-bony, horizontal defects are the most common bone defects in patients affected by periodontitis (chronic gum inflammation) and, if left untreated, they tend to worsen eventually leading to tooth loss.
Following non-surgical tooth cleaning, persisting supra-bony defects are usually surgically treated through periodontal access flap (AF) surgery, which consists in raising a gingival (gum) flap, cleaning the tooth root and repositioning the gum. However, surgical treatment of supra-bony defects represents still a challenge for clinicians due to the limited regenerative abilities of these defects and their morphology. A product combining polynucleotide with hyaluronic acid (PNHA) recently showed to promote inflammation resolution, angiogenesis and to stimulate tissue healing in reinstrumented periodontal pockets and in extra-oral wounds. This parallel-group, pilot study will test the hypothesis that combining a PNHA gel to a surgical flap will modulate the early wound healing events, which will be assessed through the expression of specific gingival crevicular fluid markers, as well as through changes in gingival blood flow (assessed via laser speckle contrast imaging), gum volume, clinical parameters and patient-reported outcome measures. The study will involve up to 24 patients and will take place at the Centre for Oral Clinical Research (QMUL). Patients will be randomised to receive either AF or AF+PNHA and will be followed up up to 3 months post surgery.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0172
Date of REC Opinion
30 Aug 2024
REC opinion
Further Information Favourable Opinion