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临床试验/CTRI/2024/05/067479
CTRI/2024/05/067479尚未招募不适用

Ridge Preservation in Maxillary Anterior Sites Comparing Xenograft Versus Indigenously Prepared Demineralized Freeze-Dried Bone Graft (DFDBA) With Subsequent Implant Placement: A Randomized Clinical Study

Jwngmashri Basumatary1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
1. Changes in the bucco-palatal width of the alveolar ridge.

研究概览

简要总结

This study focuses on preserving edentulous ridge, which are best treated with implants due to their need for substantial bone support. The aim is to use Xenograft or Demineralized Freeze- Dried Bone Allograft to graft the socket and preserve the ridge. Additionally, the study seeks to compare the effectiveness of these graft materials in preserving the ridge efficiently.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects of either sex between the age group of 18-16 years, who sign informed consent form for the study.
  • Subjects in whom extraction is indicated in at least one single rooted tooth in anterior maxilla.
  • Clinical root length should be equal to or greater than 8mm.
  • The presence of more than 50% of the buccal bone height.
  • 5.Subjects who is compliant to maintain oral hygiene instructions
  • To select only sites where the tooth location and root angulation is consistent with the ideal implant orientation, where interocclusal distance is adequate for a dental implant placement.
  • Non-smokers.

排除标准

  • Teeth adjacent to the concerned tooth should not have any periapical or active periodontal disease.
  • Pregnant women or expected pregnancy during the study period.
  • Lactating women.
  • Subjects with bone disease (Paget disease, Rickets, Osteoporosis, Multiple Myeloma etc.) and Radiographic evidence of bone tumour (benign/malignant) or cyst.
  • Subjects under long-term bisphosphonate therapy.
  • Subjects with uncontrolled systemic diseases taking immunosuppressive/ anticoagulant medications.
  • Any medical condition that contraindicates surgery.
  • Any known history of allergy to medications and graft materials used in the study.

结局指标

主要结局

1. Changes in the bucco-palatal width of the alveolar ridge.

时间窗: 1. Baseline | 2. 6months

2. Changes in the vertical height of the alveolar ridge.

时间窗: 1. Baseline | 2. 6months

3. Changes in soft tissue (width and thickness of keratinised gingiva).

时间窗: 1. Baseline | 2. 6months

次要结局

  • 1.To assess the clinical adverse effects of the grafts, if any.(2.Changes in clinical attachment level (CAL) at teeth adjacent to the extraction site)

研究者

发起方
Jwngmashri Basumatary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jwngmashri Basumatary

Maulana Azad Institute of Dental Sciences

研究点 (1)

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