Treatment of gum defects using hyaluronic acid and polynucleotides
Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides
NA · Queen Mary University of London · NCT06309719
This study is testing if adding a special gel to gum surgery helps people with gum disease heal better and faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London (other) |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT06309719 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the early molecular events in wound healing and the vascularization patterns associated with treating supra-bony defects in periodontitis patients. Participants will undergo a parallel-group intervention involving either a periodontal access flap alone or in combination with a gel formulation of hyaluronic acid and polydeoxyribonucleotides. The study will involve up to 24 patients over a minimum period of 4 months, with a total of 7 visits to assess the outcomes. The research is being conducted at the Centre for Oral Clinical Research at Queen Mary University of London.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18 and older with stage III or IV periodontitis and supra-bony defects.
Not a fit: Patients with less severe periodontal conditions or those who have not completed prior non-surgical periodontal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance healing and improve outcomes for patients with periodontal diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing periodontal healing, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London and 1 other locations
- Barts Health NHS Trust Dental Hospital — London, United Kingdom (RECRUITING)
- Centre for Oral Clinical Research (COCR) — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Elena Calciolari, DDS, MS, PhD — QMUL
- Study coordinator: Miljana Bacevic
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
- Phone: +442078823063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontal Diseases, Wound Heal, Periodontal Inflammation, Periodontal Pocket, Periodontal Attachment Loss