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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
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).
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).
Faculty of medicine and health sceince, University of Barcelona
Barcelona, Spain
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
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
Implant insertion torque
Implant insertion torque measured in N·cm
Time frame: 3 months
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
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
Postoperative pain
Visual Analog scale.
Time frame: During the first 7 postoperative days after ARP.
Analgesic medication consumption
Record of analgesics and anti-inflammatory drugs used
Time frame: During the first 7 postoperative days after ARP.
Oral health related quality of life
Evaluation of the quality of life of the patient after an ARP procedure by means of the validated questionnaire OHIP-14
Time frame: At the day of the ARP and 7 days postoperative
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