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临床试验/CTRI/2025/08/093152
CTRI/2025/08/093152尚未招募3 期

Comparative Evaluation of Implant Stability and Bone Assessment in Delayed and Immediate Implant Using Conventional and Osseodensification Drilling in Maxillary Esthetic Zone: Randomised Control Trial

Dr Komal Ware1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
2.secondary Implant Stability

研究概览

简要总结

After obtaining informed consent, participants will be seated comfortably in a dental chair under aseptic precautions. The surgical site in the maxillary esthetic zone will be anesthetized using a local anesthetic. Patients will be randomly allocated into four groups: Group 1 – delayed implant placement using the conventional drilling technique; Group 2 – delayed implant placement using the osseodensification drilling technique; Group 3 – immediate implant placement using the conventional drilling technique; and Group 4 – immediate implant placement using the osseodensification drilling technique. Osteotomy will be performed according to the assigned drilling protocol. Implants of the same system and dimensions will be placed as per the preoperative assessment. Primary implant stability will be measured at the time of placement using resonance frequency analysis (RFA), and bone changes will be assessed radiographically at baseline, 3 months, and 6 months postoperatively. All patients will receive standard postoperative care and oral hygiene instructions.

This randomized controlled clinical trial aims to compare implant stability and bone changes between conventional drilling and osseodensification techniques in both delayed and immediate implant placements in the maxillary esthetic zone. A total of four groups will be studied:

  1. Group 1: Delayed implant with conventional drilling

  2. Group 2: Delayed implant with osseodensification

  3. Group 3: Immediate implant with conventional drilling

  4. Group 4: Immediate implant with osseodensification

All implants will be placed under strict aseptic conditions using standardized surgical protocols. Implant stability will be measured using resonance frequency analysis (RFA) at placement and during follow-up. Radiographic bone level assessment will be performed at baseline, 3 months, and 6 months postoperatively. The study will help evaluate the effectiveness of osseodensification in enhancing implant stability and preserving peri-implant bone in esthetic areas.

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

  • Systemically healthy patients requiring and opting Dental Implants in maxillary Esthetic Zone 2)Sites will be Maxillary Esthetic Zone 4)Good oral hygiene and periodontal status 5)Adequate amount of bone volume at implant site allowing to perform the surgery.

排除标准

  • Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
  • Pregnant or lactating females.
  • H/o radiotherapy, smokers, parafunctional habits, acute and chronic infection.
  • Patients not willing to participate in the study or During the Study.

结局指标

主要结局

2.secondary Implant Stability

时间窗: Baseline,3rd Month,6th Month

1.Primary Implant Stability

时间窗: Baseline,3rd Month,6th Month

3.Crestal bone level

时间窗: Baseline,3rd Month,6th Month

4.Bone Density

时间窗: Baseline,3rd Month,6th Month

次要结局

  • Clinical soft tissue outcomes(BOP – Muhlemann’s Papillary Bleeding Index)

研究者

发起方
Dr Komal Ware
申办方类型
Other [{Self funded}]
责任方
Principal Investigator
主要研究者

DrKomal Ware

Government Dental College and Hospital Nagpur

研究点 (1)

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