跳至主要内容
临床试验/CTRI/2025/03/083144
CTRI/2025/03/083144尚未招募Phase 3 4

Comparative evaluation of effect of two-stage and one-stage implant surgery on peri-implant soft and hard tissues: A Randomized control trial

Dr Shreya Bhole1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月2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
20
试验地点
1
主要终点
To bypass the second stage dental implant surgery in order to reduce the treatment period and to provide the patient with early function.

研究概览

简要总结

This is single blind randomized clinical trial. The primary objective is To bypass the second stage dental implant surgery in order to reduce the treatment period and to provide the patient with early function and secondary objective is to evaluate the effect of one stage dental implant surgery on peri-implant soft and hard tissues in terms of bleeding of probing, peri-implant mucosal conditions and marginal bone loss. The following parameters will be recorded such as modified gingival index, simplified gingival index, modified plaque index at baseline, 3 months and 6 months and marginal bone loss will be recorded at baseline and 6 months at CBCT.

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 Blinded

入排标准

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

入选标准

  • Systemically healthy patients
  • Absence of oral and dental disorders
  • At least one tooth missing posterior to maxillary or mandibular canine with extraction period of 4 to 6 months.
  • Age ranging from 18 – 65 years.
  • Healed osseous architecture sufficient to receive an implant
  • Smoking fewer than 10 cigarettes/day.
  • i.e (light smoker)
  • Patients who are not indicated for soft tissue or hard tissue augmentation procedure.

排除标准

  • Patients having Systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, hepatic diseases, bone metabolic diseases, cardiovascular diseases, lung diseases, malignancies or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
  • Contra indication for implant surgery
  • Moderate or heavy smokers and chronic alcoholic patients.
  • Patients who have psychological disorders
  • No history of periodontal therapy within the previous months.
  • Local problem such as gingival or periodontal disease.

结局指标

主要结局

To bypass the second stage dental implant surgery in order to reduce the treatment period and to provide the patient with early function.

时间窗: Modified Plaque index | Modified gingival index | Simplified gingival index -baseline, 3 months and 6 months and Marginal bone loss- at baseline and 6 months

次要结局

  • To evaluate the effect of one stage dental implant surgery on peri implant soft and hard tissues in terms of bleeding of probing, peri-implant mucosal conditions and marginal bone loss.(Modified Plaque index)

研究者

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

Dr Shreya Bhole

Jawahar Medical Foundation,Annasaheb Chudaman Patil memorial Dental College , Dhule

研究点 (1)

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