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临床试验/CTRI/2024/03/064442
CTRI/2024/03/064442尚未招募Phase 3 4

Assessment of Anodised Titanium and Zirconium Dioxide Abutments on Peri Implant Soft Tissue Thickness and its optical outcome- A Randomised Clinical Trial

Sakshi Agarwal1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
1. Primary Implant Stability

研究概览

简要总结

The quality ,structure ,thickness and color of soft tissues around implant-supported FDPs (Fixed Dental Prosthesis) may affect esthetic results . Custom-made abutments are usually fabricated from Grade-5 Titanium alloys ( 90% titanium, 6% aluminium and 4% vanadium) .However ,their metallic color may still shine through the mucosa ,impairing the optical outcome.Titanium abutments are very stable from mechanical point of view ,but they have limitations in esthetically delicate areas. Anodisation of alloys is an electrolytic passivation process used to increase the thickness of natural oxide layer on the surface of metals .This method can generate a pink tone that may mask the metallic color of titanium abutments in esthetic region.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Implant placement in anterior maxillary region.
  • Edentulous ridge having natural teeth both mesially and distally.
  • Presence of more than 2mm band of Keratinized tissue.
  • Systematically healthy patients.
  • Subjects with good plaque control ,showing good compliance, willing to participate in study.

排除标准

  • a) Current untreated gingivitis or periodontitis b) Patient under drugs than can influence healing c) Pregnant or lactating women d) Patients with inadequate oral hygiene or motivation for adequate home care.

结局指标

主要结局

1. Primary Implant Stability

时间窗: 1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement | 2. Time Point for Secondary Implant Stability is- 3 months after Implant Placement

2. Secondary Implant Stability

时间窗: 1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement | 2. Time Point for Secondary Implant Stability is- 3 months after Implant Placement

次要结局

  • 1. Soft Tissue Thickness at Peri Implant Site(2. Optical outcome of Anodised Titanium Abutment & Zirconium Dioxide Abutment)

研究者

发起方
Sakshi Agarwal
申办方类型
Other [Self Sponsor]
责任方
Principal Investigator
主要研究者

Sakshi Agarwal

IMS BHU , Varanasi

研究点 (1)

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