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临床试验/CTRI/2024/04/065588
CTRI/2024/04/065588尚未招募不适用

Assessment Of Soft Tissue Changes after Implant Placement Using Flap Vs Flapless Technique by Dynamic Navigation System- A Randomized Clinical Triall

Dr Thota Saranya1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月25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
32
试验地点
1
主要终点
The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge

研究概览

简要总结

The purpose of the present study is to evaluate the impact of the Flapless implant placement technique compared to traditional flap elevation using dynamic navigation system on soft tissue changes. In this study 32 patients will be recruited from the outpatient department of periodontology and Implantology. In the test group, Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw. Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig. Implant placement will be done through navigation. In the control group of patients, Implant planning will be done as per prosthetic considerations by attaching tracker to the handpiece and jaw. Tracing and registering will be done by calibration of handpiece and drill tips on calibrator jig. A mid-crestal incision will be made and sulcular incisions will be made on the mesial and distal aspects of the adjacent teeth with a No.15 blade, and a full thickness flap will be elevated. Implant placement will be done through navigation. The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge and crestal bone loss will be measured at baseline, 3 months and 6 months. Implant stability will be assessed at baseline and 3 months. Wound Healing Index will be assesses at 1 week, 3 weeks and 1 month. Patient reported outcome measures will be assessed at 2 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with healthy periodontal status
  • Edentulous mandibular posterior sites
  • Adequate bone depth and width for implant placement.

排除标准

  • 1.Patients with uncontrolled systemic diseases
  • Pregnancy or lactating women
  • Chronic smokers
  • Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C)
  • Patients undergoing radiation therapy
  • Patients under bisphosphonate therapy 7.Patients under antibiotic therapy.

结局指标

主要结局

The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge

时间窗: The soft tissue changes which include Soft tissue thickness, Width of keratinised mucosa, Papillary Height measurement, Buccolingual width of alveolar ridge will be measured at baseline, 3 months and 6 months

次要结局

  • 1.Implant stability(2.Crestal Bone loss)

研究者

发起方
Dr Thota Saranya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Thota Saranya

Vishnu Dental College

研究点 (1)

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