Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction

Adrià Jorba García

Status: Not yet enrolling

Conditions: Bone Substitutes; Tooth Extraction Status Nos

Treatments: Procedure: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix; Procedure: Alveolar ridge preservation using DBBM + collagen matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT06633211

Regenfast

Details and patient eligibility

About

Alveolar ridge resorption after tooth extraction is a physiological process that continues throughout the patient's life due to the loss of the periodontal ligament and lack of mechanical stimulation. Alveolar ridge preservation (ARP) techniques aim to minimize dimensional changes in the ridge after tooth extraction. These techniques involve grafting the socket to fill the bed and/or sealing it with a biomaterial. Currently, there is a polynucleotide and hyaluronic acid-based gel (Regenfast®) on the market that has proven useful in treating residual periodontal defects. Hyaluronic acid-based gels also appear to enhance the regenerative potential of critical bone defects in both in-vitro studies on rats and clinical studies. Therefore, this study aims to evaluate the clinical and histological effects of polynucleotide and hyaluronic acid-based gel in alveolar preservation procedures.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (>18 years) who need the extraction of a single non-molar tooth in the mandible or maxilla.
• ASA I or II
• Intact post-extraction socket or with only one wall dehiscence (buccal or lingual) of no more than 50% of the socket.
• The treatment plan must include the replacement of the tooth to be extracted by placing an implant and an implant-supported prosthesis.

Exclusion criteria

• Mandibular incisors and molars.
• Acute infection associated with the tooth that needs to be extracted.
• Uncontrolled systemic disease.
• Pregnant patient.
• Patient under treatment with antiresorptives drugs (bisphosphonates or Receptor Activator of Nuclear Factor Kappa-B Ligand (i.e., Denosumab)) or antiangiogenics.
• Smokers (>10 cigarettes a day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

DBBM + collagen matrix

Active Comparator group

Description:

An alveolar ridge preservation will be performed using particulate xenograft DBBM (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland), and the alveolus will be sealed with a collagen matrix (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland).

Treatment:

Procedure: Alveolar ridge preservation using DBBM + collagen matrix

DBBM + Regenfast + collagen matrix

Experimental group

Description:

An alveolar preservation will be performed by means of a particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) mixed with polynucleotide and hyaluronic acid-based gel (Regenfast®). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland).

Treatment:

Procedure: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix