Bone Substitutes, Tooth Extraction Status Nos
Conditions
Keywords
Alveolar Ridge preservation, Guided bone regeneration
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.
Interventions
PROCEDUREAlveolar ridge preservation using DBBM + Regenfast + collagen matrix
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).
PROCEDUREAlveolar ridge preservation using DBBM + collagen matrix
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).
Sponsors
Adrià Jorba García
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Due to the interventional nature of the study, the surgeon cannot be blinded. A randomization sequence will be generated, and each patient will be assigned a number. To ensure allocation concealment, the surgeon will be blinded to the group assignment of each patient until just before performing the alveolar preservation procedure. The investigator responsible for conducting the radiological measurements and the histomorphometric study will be blinded to the patient's group assignment.
Intervention model description
Two parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Postoperative pain | During the first 7 postoperative days after ARP. | Visual Analog scale. |
Countries
Spain
Contacts
Primary ContactAdria Jorba garcia, DDS, MS
Outcome results
None listed