NCT06309719 Hyaluronic Acid and Polynucleotides for Supra-bony Defects
| NCT ID | NCT06309719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Periodontal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-10-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.
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.
Contact & Investigator
Elena Calciolari, DDS, MS, PhD
PRINCIPAL INVESTIGATOR
QMUL
Frequently Asked Questions
Who can join the NCT06309719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309719 currently recruiting?
Yes, NCT06309719 is actively recruiting participants. Contact the research team at BHNT.Clinicaloralresearchcentre@nhs.net for enrollment information.
Where is the NCT06309719 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06309719 clinical trial?
NCT06309719 is sponsored by Queen Mary University of London. The principal investigator is Elena Calciolari, DDS, MS, PhD at QMUL. The trial plans to enroll 24 participants.