Hyaluronic Acid and Polynucleotides for Supra-bony Defects

Launched by QUEEN MARY UNIVERSITY OF LONDON · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new treatment using hyaluronic acid and polynucleotides works for people with certain types of gum disease, specifically those with supra-bony defects. These defects are areas where the gum tissue has been damaged and the bottom of the gum pocket is located above the bone. The study aims to understand how this treatment helps with healing and blood vessel growth compared to a standard surgical procedure.

To participate, you need to be a healthy adult, at least 18 years old, and have a severe form of gum disease affecting two to four adjacent teeth. You should have already received some non-surgical treatment for your gum disease within the last four months. However, there are some exclusions, such as having certain dental issues, being a heavy smoker, or having serious health conditions like uncontrolled diabetes. If you join, you can expect to undergo a procedure that may help improve your gum health, and the study will closely monitor your healing process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Systemically healthy males and females ≥18 years old
• • Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
• • Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \> 5 mm, following non-surgical periodontal therapy (NSPT). If \>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.
• • If defect presents with an intrabony component, this should be ≤2 mm.
• • Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
• • Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%
• Exclusion Criteria:
• • Teeth with degree III mobility
• • Multi-rooted teeth with grade ≥2 furcation involvement
• • Heavy smokers (≥10 cigarettes a day)
• • Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
• • Previous periodontal surgery in the area selected for the study
• • History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
• • Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
• • History of alcohol or drug abuse
• • Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
• • In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
• • Self-reported pregnancy or lactation.