Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction
- Conditions
- Bone SubstitutesTooth Extraction Status Nos
- Interventions
- Procedure: Alveolar ridge preservation using DBBM + collagen matrixProcedure: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix
- Registration Number
- NCT06633211
- Lead Sponsor
- Adrià Jorba García
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DBBM + collagen matrix Alveolar ridge preservation using DBBM + collagen matrix 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). DBBM + Regenfast + collagen matrix Alveolar ridge preservation using DBBM + Regenfast + collagen matrix 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).
- Primary Outcome Measures
Name Time Method Histomorphometric results 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 Outcome Measures
Name Time Method Visual evaluation of socket healing. 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
Implant insertion torque 3 months Implant insertion torque measured in N·cm
Need for additional bone regeneration for implant placement 3 months Evaluation of the feasibility to place dental implant without needing additional bone regeneration
Dimensional changes Measurement at the day of the ARP and 3 months Changes in the horizontal and vertical dimensions of the alveolar ridge after the ARP
Postoperative pain During the first 7 postoperative days after ARP. Visual Analog scale.
Analgesic medication consumption During the first 7 postoperative days after ARP. Record of analgesics and anti-inflammatory drugs used
Oral health related quality of life 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
Trial Locations
- Locations (1)
Faculty of medicine and health sceince, University of Barcelona
🇪🇸Barcelona, Spain