Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets

Официальное название

Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is: Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets. Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement. Participants will: Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure. Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material. Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement. Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.

Вмешательства

• Процедура Alveolar ridge preservation
  Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Первичные конечные точки

• Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months [Срок оценки: 3 months]
• Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months) [Срок оценки: 3 months]
• Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months) [Срок оценки: 6 months]
• Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating) [Срок оценки: 2 weeks following tooth extraction and alveolar ridge preservation]
• Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating) [Срок оценки: 2 weeks after dental implant placement]
• Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction [Срок оценки: At the time of implant placement (3 or 6 months)]
• Patient reported outcomes (number of days of total or partially impaired activity) following implant placement [Срок оценки: 4 months post implant placement]
• Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100) [Срок оценки: 2 weeks following tooth extraction and alveolar ridge preservation]
• Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100) [Срок оценки: 3 months following tooth extraction and alveolar ridge preservation]
• Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100) [Срок оценки: 6 months following tooth extraction and alveolar ridge preservation]
• Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100) [Срок оценки: Up to 30 days post implant crown delivery]
• Implant survival rate [Срок оценки: 1 year post implant loading]
• Marginal bone level changes [Срок оценки: 1 year post implant loading]

Критерии участия

Критерии включения

• 18 years of age or older
• ASA (American Society of Anesthesia) status I or II
• Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV
• Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021)
• Radiographic evidence of at least 3 mm of residual bone wall height
• Presence of at least one adjacent tooth to the extraction site
• Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis

Критерии исключения

• Extraction of multiple adjacent teeth
• Acute infection associated with the tooth to be extracted or with adjacent teeth
• Current smokers (>10 cigarettes per day)
• Uncontrolled diabetes mellitus (HbA1c >7.0)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Diseases or medications that may compromise normal wound healing

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Ninth People's Hospital — Шанхай

Публикации

• Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. PMID 24966231
• Dai A, Li HY, Kang S, Lin R, Huang JP, Mao F, Ding PH. Effect of alveolar ridge preservation at periodontally compromised molar extraction sockets: A retrospective cohort study. J Periodontol. 2025 Jan;96(1):9-20. doi: 10.1002/JPER.24-0064. Epub 2024 Jun 17. PMID 38884702
• Ben Amara H, Kim JJ, Kim HY, Lee J, Song HY, Koo KT. Is ridge preservation effective in the extraction sockets of periodontally compromised teeth? A randomized controlled trial. J Clin Periodontol. 2021 Mar;48(3):464-477. doi: 10.1111/jcpe.13412. Epub 2021 Jan 19. PMID 33316099
• Zellner JW, Allen HT, Kotsakis GA, Mealey BL. Wound healing after ridge preservation: A randomized controlled trial on short-term (4 months) versus long-term (12 months) histologic outcomes. J Periodontol. 2023 May;94(5):622-629. doi: 10.1002/JPER.22-0187. Epub 2023 Jan 10. PMID 36527199
• Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18. PMID 36345818

Идентификаторы

NCT: NCT06654141 · SDC-2024-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗