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

ConditionsBone SubstitutesTooth Extraction Status Nos
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdrià Jorba García

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Mandibular incisors and molars.

Acute infection associated with the tooth that needs to be extracted.

Uncontrolled systemic disease.

Pregnant patient.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alveolar ridge preservation using DBBM + Regenfast + collagen matrix

    Procedure/Surgery

    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/Surgery

    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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: DBBM + collagen matrixActive comparator 1 intervention
Group B: DBBM + Regenfast + collagen matrixExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Histomorphometric results

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.

Time frame
3 months

Secondary outcomes

1

Visual evaluation of socket healing.

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

Time frame
At 1 week and 12 weeks
2

Implant insertion torque

Implant insertion torque measured in N·cm

Time frame
3 months
3

Need for additional bone regeneration for implant placement

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

Time frame
3 months
4

Dimensional changes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adrià Jorba García

Lead sponsor

University of Barcelona

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: