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Clinical Trials in Italy / NCT07099846
Recruiting Not applicable

Hyaluronic Acid and Polynucleotides in Ridge Preservation

NCT07099846 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Parma
Phase
Not applicable
Started
2025-06-09
Last updated
2025-09-08

Condition(s) studied

Socket PreservationImplant-supported Single CrownsHyaluronic AcidCAD-CAM

Investigational drug(s) / intervention(s)

regeneration of post extraction socket with biomaterials

regeneration of post extraction socket with biomaterials: after tooth extraction, in the test group we will place a demineralised bovine bone graft mixed with a gel containing hyaluronic acid and polynucleotide and we will cover the entrance of the socket with a collagen matrix

Study summary

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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma Parma Italy Recruiting
Centro di Odontoiatria Parma Italy Recruiting

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Investigation of in Vivo Endogenous and/or Exogenous Production of Phenolic Metabolites Using (un)Targeted Metabolomics Recruiting
Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT) Active, not recruiting

Other trials for the same condition

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07099846 on ClinicalTrials.gov ↗ ← All trials in Italy