Hyaluronic Acid and Polynucleotides in Ridge Preservation

NCT07099846 | Recruiting

• 1 other identifier: P-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Socket Preservation; Implant-supported Single Crowns; Hyaluronic Acid; CAD-CAM

Keywords

alveolar ridge preservation; hyaluronic acid; polynucleotides; digital workflow; CAD-CAM; Implant rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in alveolar ridge width at 4 months post extraction between study groups

  This is a superiority outcome evaluating horizontal ridge width changes at four months post-extraction between test and contro group with the help of a CBCT scan.

  4 months after tooth extraction (visit 6)

Secondary Outcomes (12)

• quality of newly formed bone

  4 months post extraction (visit 6)

• 3D volume changes

  4 months post extraction (visit 6)

• changes in protein expression

  3, 7 and 14 days post extraction (Visit 3, 4, 5)

• Profilometric changes

  3, 7, 14 days and at 4 months post extraction (visit 3, 4, 5)

• Change in post operative discomfort

  3, 7 and 14 days after extraction (visit 3, 4, 5)

Study Arms (2)

Spontaneous post extraction healing

NO INTERVENTION

The control group will not receive any biomaterial in the post extraction socket

Alveolar ridge preservation

EXPERIMENTAL

In the group assigned to receive socket preservation, particulate deproteinizied bovine bone mineral (Bio-oss, Geistlich biomaterials) mixed with a gel containing hyaluronic acid and polynucleotides (Regenfast, Mastelli) will be placed in the socket without overfilling it and the socket will be sealed with a porcine collagen matrix (Mucograft seal, Geistlich), Any remaining PNHA gel will be placed at the entrance of the socket and on the surrounding gingival tissue

Device: regeneration of post extraction socket with biomaterials

Interventions

regeneration of post extraction socket with biomaterials DEVICE

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

Also known as: alveolar ridge preservation, socket preservation

Alveolar ridge preservation

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Parma: lead
• Geistlich Pharma AG: collaborator

Study Sites (2)

Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma

Parma, 43126, Italy

RECRUITING

Centro di Odontoiatria

Parma, 43126, Italy

RECRUITING

Related Publications (3)

• Guizzardi S, Galli C, Govoni P, Boratto R, Cattarini G, Martini D, Belletti S, Scandroglio R. Polydeoxyribonucleotide (PDRN) promotes human osteoblast proliferation: a new proposal for bone tissue repair. Life Sci. 2003 Aug 29;73(15):1973-83. doi: 10.1016/s0024-3205(03)00547-2.

  PMID: 12899922 BACKGROUND

• Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available.

  PMID: 33480222 BACKGROUND

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

Central Study Contacts

Elena Calciolari, DDS, MS, PhD

CONTACT

+390521903640; elena.calciolari@unipr.it

Federico Rivara, DDS, MS, PhD

CONTACT

+390521903640; federico.rivara1@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: August 1, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)