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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBBM + collagen matrix | Active Comparator | 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). |
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| DBBM + Regenfast + collagen matrix | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 1 week and 12 weeks |
| Implant insertion torque |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adria Jorba garcia, DDS, MS | Contact | +34 699183949 | adriajorba@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adria Jorba Garcia, DDS, MS | University of Barcelona | Principal Investigator |
| Javier Bara-Casaus, MD, PhD | University of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine and health sceince, University of Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31215112 | Background | Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131. | |
| 30623987 |
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Two parallel groups
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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.
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| 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). |
|
Implant insertion torque measured in N·cm
| 3 months |
| Need for additional bone regeneration for implant placement | Evaluation of the feasibility to place dental implant without needing additional bone regeneration | 3 months |
| Dimensional changes | Changes in the horizontal and vertical dimensions of the alveolar ridge after the ARP | Measurement at the day of the ARP and 3 months |
| Postoperative pain | Visual Analog scale. | During the first 7 postoperative days after ARP. |
| Analgesic medication consumption | Record of analgesics and anti-inflammatory drugs used | 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 | At the day of the ARP and 7 days postoperative |
| Background |
| Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. |
| 36189651 | Background | Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23. |
| 21689163 | Background | de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21. |
| 38363180 | Background | Cairo F, Cavalcanti R, Barbato L, Nieri M, Castelluzzo W, di Martino M, Pilloni A. Polynucleotides and Hyaluronic Acid (PN-HA) Mixture With or Without Deproteinized Bovine Bone Mineral as a Novel Approach for the Treatment of Deep Infrabony Defects: A Retrospective Case Series. Int J Periodontics Restorative Dent. 2025 Mar 6;45(2):153-163. doi: 10.11607/prd.7065. |