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临床试验/CTRI/2024/05/067565
CTRI/2024/05/067565尚未招募4 期

A Comparative Evaluation of Mean Crestal Bone Level Changes among Hydrophobic, Hydrophilic, and Laser Micro-Grooved Dental Implants Post 1 Year of Immediate Loading – A Randomised Clinical Control Trial.

self funding1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Mean Crestal bone level changes in mm to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control SLA and Test groups SLA-Active and LMGI

研究概览

简要总结

Dental implants have emerged as a popular option for replacing missing teeth due to their biocompatibility and ability to provide a stable foundation for replacement teeth. While Moraschini et al. (2015) showed high success rates over 10 years, there’s a gap in comparing implant designs like hydrophobic (SLA), hydrophilic (SLA active), and Laser Microgrooved Implants (LMGI). This research needs to address long-term bone level changes, particularly the Mean Crestal Bone Level (MCBL), which is crucial for assessing implant success (Jamcoski et al., 2022). This gap indicates a need for groundbreaking research to address the lack of evidence on long-term bone level changes associated with these micro designs. The lack of literature comparing the Mean Crestal Bone Level changes among Hydrophobic, Hydrophilic, and Laser Micro-Grooved Dental Implants Post 1 Year of Immediate Loading underscores the need for novel research in this area. The aim of this study is to evaluate and compare the Mean Crestal bone level changes in Hydrophilic, Hydrophobic and Laser Micro grooved dental implants post 1-year immediate loading. Though there are multitude of evidences to favor these micro-modifications and their implications on Mean Crestal Bone level changes individually, there are scarcity in the literature on comparison of various micro modified implant systems**.**

To the best of our knowledge there are no literature evidence comparing these there primitive micro-modified implant designs in specific i.e., hydrophobic (SLA), hydrophilic (SLA active) and laser micro-grooved implants.

Thus, comparison of these three primitive microdesigns i.e., hydrophobic (SLA), hydrophilic (SLA active) and Laser Microgrooved Implants (LMGI) would be a ground breaking and forefront evidence to fill the lacunae pertaining to the evidences evaluating long term bone level changes in relevance to these three microdesign. Such evidence would be definitive clinical guideline in appropriate implant selection entailing the specific anatomical demands

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Male or female patients with age group between 25 to 60 years Patients not contraindicated for periodontal or implant surgery One bounded edentulous space ie a single tooth missing with intact proximal teeth primarily in the lower posteriors premolars and molars with sufficient bone quantity to allow implant placement Patients should be cooperative motivated and oral hygiene conscious Sufficient bone height at least 13mm and sufficient bone width at least 6mm should be present Presence of local factors without signs of clinical inflammation Stable occlusion with no para functional habits.

排除标准

  • Presence of active periodontal disease at the time of implant surgery Patients who did not accept to comply for 1 year follow-up were excluded from the study Patient diagnosed with known systemic diseases Bone disorders like hyperparathyroidism osteoporosis or Pagets disease Patients who are under steroids antiinflammatory and bisphosphonates in the past 6 months Patients who are treated with radiotherapy or chemotherapeutic agents.
  • Chronic alcoholics or drug abuse Smokers.

结局指标

主要结局

Mean Crestal bone level changes in mm to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control SLA and Test groups SLA-Active and LMGI

时间窗: subjects will be followed at baseline, 6 months and 1 year

Implant survival rates in percentage to be assessed at 1 year with radiographic and clinical assessment between Control SLA and Test groups SLA Active and LMGI

时间窗: subjects will be followed at baseline, 6 months and 1 year

次要结局

  • To evaluate and compare the Relative position of gingival margin in mm at the implant site of Control SLA and Test groups SLA-Active and LMGI at Baseline 6 months and 1 year post loading(To assess the Implant stability quotient ISQ values using resonance frequency analysis RFA during Immediate Loading protocol)

研究者

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

Dr Dhivya Dharshini K

SRM Dental College, Ramapuram

研究点 (1)

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