Preserving the jawbone after a tooth extraction using hyaluronic acid and polynucleotides

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.