Polydeoxyribonucleotide (PDRN) promotes human osteoblast proliferation: a new proposal for bone tissue repair.
Stefano Guizzardi, Carlo Galli, Paolo Govoni...
https://pubmed.ncbi.nlm.nih.gov/12899922Actively Recruiting
Phase Not Applicable
Age: 25Years +
All Genders
ID07099846
The Use of Hyaluronic Acid and Polynucleotides in Ridge Preservation Sites Rehabilitated With a Complete Full Digital Workflow
Led by University of Parma · Updated on 2025-09-08
40
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Parma
Lead Sponsor
G
Geistlich Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel to preserve bone after tooth extraction and to test a fully-digital method for placing dental implants. This single-center, double-blind randomized controlled trial involves 40 patients needing a single tooth extraction, comparing spontaneous healing to the use of the bone graft and PNHA gel for alveolar ridge preservation. Participants will be randomly assigned to either a control group with no biomaterial placed in the extraction socket or to a treatment group receiving a bone graft mixed with PNHA gel and covered with a collagen matrix. Four months after extraction, an implant will be placed in the site and rehabilitated using a fully-digital workflow. The study includes 11 visits over at least 20 months, with follow-up continuing up to 12 months after implant loading. Patients will undergo two 3D x-rays to assess bone changes immediately after extraction and at 4 months, plus clinical evaluations of healing and questionnaires about quality of life and therapy perception. Wound fluid samples will be collected during early healing, and bone tissue samples will be taken at implant placement for detailed analysis. The main measure is the change in alveolar ridge width at 4 months, along with assessments of bone quality, protein expression, healing indexes, implant success, and patient satisfaction.
CONDITIONS
Brief Title
Hyaluronic Acid and Polynucleotides in Ridge Preservation
Who Can Participate
Age: 25Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 25-year-old males and females
- Good systemic health based on self-assessment
- Presence of an unrestorable or hopeless tooth with periodontal attachment and at least two-thirds of buccal bone preserved
- Full mouth bleeding and plaque scores less than or equal to 25%
You will not qualify if you...
- Uncontrolled or untreated periodontal disease
- History of local head and neck radiation therapy in the past 5 years
- Acute endodontic lesion in the tooth to be extracted or neighboring areas
- Medical history including uncontrolled diabetes, liver or kidney disease, rheumatoid arthritis, osteoporosis, or infectious diseases like HIV
- History of alcohol or drug abuse
- Smoking 10 or more cigarettes per day
- Pregnancy or lactation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are recruited among patients routinely seen in new patient and follow-up clinics
Treatment
Duration - 4 months
Participants undergo atraumatic tooth extraction followed by either alveolar ridge preservation with biomaterials or unassisted socket healing.
11 visits over a minimum of 20 months; early post-extraction visits occur at 3, 7, and 14 days post extraction
Follow-up
Duration - Up to 12 months post implant loading
Participants are followed up for implant placement, prosthetic rehabilitation, and assessments of implant success and satisfaction.
Visits include implant placement within 5 months post extraction and follow-ups up to 12 months post loading
Trial Site Locations
Total: 2 locations
1
Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma
Parma, Italy, 43126
Actively Recruiting
2
Centro di Odontoiatria
Parma, Italy, 43126
Actively Recruiting
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Research Team
E
Elena Calciolari, DDS, MS, PhD
F
Federico Rivara, DDS, MS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Polynucleotide biogel enhances tissue repair, matrix deposition and organization.
M T Colangelo, P Govoni, S Belletti...
https://pubmed.ncbi.nlm.nih.gov/33480222Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis.
Gustavo Avila-Ortiz, Leandro Chambrone, Fabio Vignoletti
https://pubmed.ncbi.nlm.nih.gov/30623987