Actively Recruiting
Hyaluronic Acid and Polynucleotides in Ridge Preservation
Led by University of Parma · Updated on 2025-09-08
40
Participants Needed
2
Research Sites
151 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
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental implant. 40 patients in need for a single tooth extraction will be recruited at Centro di Odontoiatria, Università di Parma and they will be randomly assigned to 2 groups: extraction and spontaneous healing or extraction and regeneration of the site with a bovine-derived bone graft combined with a PNHA gel. At 4 months after extraction an implant will be placed in the extraction site, which will be rehabilitated with a fully-digital workflow and patients will be followed up at up to 12 months post rehabilitation. Two 3D x-rays with a small field of view will be performed immediately after extraction and at 4 months post extraction to plan implant placement. These images will also be used to assess changes in the dimension of the post extraction bone (primary outcome). As part of the study different questionnaires will be administered to assess quality of life and perception of the therapy and the wound exudate in the area of the extraction will be collected non invasively with a collagen sponge to assess the expression of different proteins during the early healing days. On the day of implant placement a sample of bone tissue will also be collected as part of the bone drilling and histologically analysed.
CONDITIONS
Official Title
Hyaluronic Acid and Polynucleotides in Ridge Preservation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 25 years or older
- Good overall health as self-assessed
- Have an unrestorable or hopeless tooth with periodontal support and at least two-thirds of buccal bone preserved
- Full mouth bleeding and plaque scores of 25% or less
You will not qualify if you...
- Uncontrolled or untreated periodontal disease
- History of head and neck radiation therapy within the past 5 years
- Acute endodontic lesion in the tooth to be extracted or neighboring areas (chronic asymptomatic lesions allowed)
- Uncontrolled diabetes, liver or kidney disease, or serious medical conditions affecting bone metabolism such as rheumatoid arthritis or osteoporosis
- Transmittable diseases like HIV
- History of alcohol or drug abuse
- Smoking 10 or more cigarettes per day
- Currently pregnant or breastfeeding
AI-Screening
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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
Research Team
E
Elena Calciolari, DDS, MS, PhD
CONTACT
F
Federico Rivara, DDS, MS, PhD
CONTACT
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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