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临床试验/ACTRN12624000190505
ACTRN12624000190505尚未招募2 期

The clinical effects of the adjunctive use of a viscoelastic gel containing hyaluronic acid and polynucleotides with deproteinised bovine bone mineral and collagen matrix in alveolar ridge preservation: A Pilot Randomised Controlled Clinical Trial

The University of Western Australia0 个研究点目标入组 20 人开始时间: 2024年2月27日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
21 Years 至 o limit(—)
性别
All

入选标准

  • Patient-specific inclusion criteria
  • Age greater than or equal to 21 years old
  • Females and Males
  • Systemic and local conditions compatible with implant placement and experimental procedures
  • Patient willing and fully capable of complying with the study protocol.
  • Tooth and site-specific inclusion criteria
  • To be considered the tooth site will have to fulfil all the following criteria:
  • Terminal prognosis of a single-rooted incisor, canine or premolar tooth requiring extraction.
  • Extraction may be indicated due to trauma, endodontic complication (root fracture) or unrestorable caries.
  • Periodontal status: adequate oral hygiene, Bleeding on probing <20%, Plaque index < 20%
  • Single tooth extraction with no missing adjacent teeth.
  • Accepted characteristics of an extraction socket site:
  • o Buccal socket wall with >50% of the buccal bone height is present.
  • o Sufficient space is required for implant placement.

排除标准

  • Patient-specific exclusion criteria
  • Current heavy smoking (>10 cigarettes/day for >6 months prior to and at the time of the surgical procedure)
  • Patients with uncontrolled diabetes: defined as HbA1c >7.0
  • Severe hematologic disorders, such as haemophilia or leukemia
  • Liver or kidney failure
  • History of radiation therapy in the head and neck area
  • History of chemotherapy
  • Systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing
  • Past (within 6 months prior to enrolment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or osseous healing
  • Documented allergy to dental materials involved in the experimental protocol
  • Pregnancy or lactation
  • Chronic drug abuse
  • Psychological disorders: mental disabilities that may interfere with reading, understanding and signing the informed consent and/or with following study-related instructions.
  • Moreover, participants immediately exited the study upon:
  • Request to withdraw from further participation
  • Development of acute dental, peri-implant or oral conditions requiring treatment
  • Development of conditions conflicting with the inclusion criteria listed above.
  • Failure to comply with study instructions/requirements.
  • Site-specific exclusion criteria:
  • Missing adjacent teeth
  • Buccal socket wall with more than 3mm or 25% of the coronal mid-buccal vertical wall lost.
  • Site with acute infection (i.e pain or presence of abscess).

研究者

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