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

Официальное название

Clinical and Histological Effects of the Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction: A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Процедура Alveolar 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).
• Процедура Alveolar 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).

Первичные конечные точки

• Histomorphometric results [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Visual evaluation of socket healing. [Срок оценки: At 1 week and 12 weeks]
• Implant insertion torque [Срок оценки: 3 months]
• Need for additional bone regeneration for implant placement [Срок оценки: 3 months]
• Dimensional changes [Срок оценки: Measurement at the day of the ARP and 3 months]
• Postoperative pain [Срок оценки: During the first 7 postoperative days after ARP.]
• Analgesic medication consumption [Срок оценки: During the first 7 postoperative days after ARP.]
• Oral health related quality of life [Срок оценки: At the day of the ARP and 7 days postoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of medicine and health sceince, University of Barcelona — Barcelona

Публикации

• 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 Sup PMID 31215112
• 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. PMID 30623987
• 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. PMID 36189651
• 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. PMID 21689163
• 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. PMID 38363180

Идентификаторы

NCT: NCT06633211 · Regenfast

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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