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NCT Number: NCT06633211

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

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.

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Key information

Conditions

Bone Substitutes Tooth Extraction Status Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine and health sceince, University of Barcelona

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Alveolar ridge preservation using DBBM + Regenfast + collagen matrix

Procedure

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using 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) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

Alveolar ridge preservation using DBBM + collagen matrix

Procedure

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

Primary outcomes

  1. Histomorphometric results

    Time frame: 3 months

    After 3 months of the ARP, A trephine with an internal diameter of 2.5 mm and a maximum length of 15 mm will be used to extract a bone core for histological analysis. Histological analyses will be performed on the entire sample area by calibrated and blinded examiners using open-source software (ImageJ, NIH). The areas of mineralized tissue and remaining xenograft material will be quantified based on their appearance and expressed as a percentage of the total area. The remaining area in the sample will be classified as non-mineralized tissue.

Secondary outcomes

  1. Visual evaluation of socket healing.

    Time frame: At 1 week and 12 weeks

    Clinician will evaluate the healing of the socket based on a Healing index described by Avila-Ortiz, et al., 2018

  2. Implant insertion torque

    Time frame: 3 months

    Implant insertion torque measured in N·cm

  3. Need for additional bone regeneration for implant placement

    Time frame: 3 months

    Evaluation of the feasibility to place dental implant without needing additional bone regeneration

  4. Dimensional changes

    Time frame: Measurement at the day of the ARP and 3 months

    Changes in the horizontal and vertical dimensions of the alveolar ridge after the ARP

  5. Postoperative pain

    Time frame: During the first 7 postoperative days after ARP.

    Visual Analog scale.

  6. Analgesic medication consumption

    Time frame: During the first 7 postoperative days after ARP.

    Record of analgesics and anti-inflammatory drugs used

  7. Oral health related quality of life

    Time frame: At the day of the ARP and 7 days postoperative

    Evaluation of the quality of life of the patient after an ARP procedure by means of the validated questionnaire OHIP-14

Study contacts

Contact information is provided by the study sponsor or research team.

Adria Jorba garcia, DDS, MS

CONTACT

[email protected]

+34 699183949

Sponsors and collaborators

Lead sponsor

Adrià Jorba García

Other

Registry information

Official study title

Clinical and Histological Effects of the Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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