Preserving the jawbone after a tooth extraction using hyaluronic acid and polynucleotides
The Use of Hyaluronic Acid and Polynucleotides in Ridge Preservation Sites Rehabilitated With a Complete Full Digital Workflow
This trial will test whether filling an extraction socket with a bovine bone graft plus a polynucleotide-rich hyaluronic acid gel helps preserve the jawbone and supports implant placement in adults needing a single tooth extraction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | University of Parma Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Parma and 1 other locations) |
| Trial ID | NCT07099846 on ClinicalTrials.gov |
What this trial studies
This single-centre, double-blind randomized trial will enroll 40 adults needing a single tooth extraction and randomly assign them to either socket grafting with bovine-derived bone (DBBM) mixed with a polynucleotide-rich hyaluronic acid (PNHA) gel and sealed with a collagen matrix, or to unassisted spontaneous healing. Small-field CBCT scans will be taken immediately after extraction and at four months to measure changes in alveolar ridge width, and implants will be placed at four months using a fully digital CAD-CAM workflow. Early healing, patient discomfort (VAS), soft tissue healing scores, and wound exudate samples will be collected during the first two weeks, and participants will be followed through implant rehabilitation and up to 12 months post-rehabilitation. The trial compares dimensional preservation of the socket and clinical outcomes between the regenerative approach and spontaneous healing.
Who should consider this trial
Good fit: Adults aged 25 or older in generally good health who require a single non-restorable tooth extraction with at least two-thirds of the buccal bone intact and who have good oral hygiene are the ideal candidates.
Not a fit: Patients with uncontrolled periodontal disease, acute local infection at the extraction site, heavy smokers (≥10 cigarettes/day), uncontrolled systemic conditions affecting bone metabolism, recent head/neck radiation, pregnancy or lactation, or other listed exclusions are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could better preserve alveolar ridge dimensions after extraction, making implant placement easier and improving aesthetic and functional outcomes.
How similar studies have performed: Use of DBBM for socket preservation has been shown to reduce ridge resorption in prior studies, but the specific combination with a PNHA gel and the pairing with a fully digital rehabilitation workflow is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥25-year-old males and females; * good systemic health (self-assessment); * presence of an unrestorable/hopeless tooth with periodontal attachment and buccal bone preserved at least for 2/3rd of the root and not associated with acute periapical pathology; * full mouth bleeding and plaque scores ≤ 25% Exclusion Criteria: * uncontrolled or untreated periodontal disease; * history of local (head and neck) radiation therapy in the past 5 years; * acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible); * medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. HIV-related disease); * history of alcohol or drug abuse; * smokers of ≥10 cigarettes a day; * self-reported pregnancy or lactation.
Where this trial is running
Parma and 1 other locations
- Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma — Parma, Italy (Recruiting)
- Centro di Odontoiatria — Parma, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Calciolari, DDS, MS, PhD
- Email: elena.calciolari@unipr.it
- Phone: +390521903640
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.