CTRI/2025/04/084998尚未招募不适用
Comparative evaluation of crestal bone level changes between SLA, SLA ACTIVE and LASER MICROGROOVED dental implants using minimally invasive flapless technique in diabetic individuals- A randomized controlled clinical trial
N. Shreenidhi Utthamambigai1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年1月5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
- 42
- 试验地点
- 1
- 主要终点
- and 1 year with standardized Intra oral periapical radiographs in Control
研究概览
简要总结
This study evaluates how microgeometrical surface modifications of dental implants impact stability, crestal bone preservation, peri-implant health, and implant survival, particularly in diabetic individuals. The findings will provide insights to optimize implant selection, treatment planning, and patient care, contributing to improved long-term success and patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 30 to 60 years with HbA1c levels ranging from 8.1 to 10 are eligible for the study.
- •Participants should be on oral hypoglycemic drugs, such as Metformin, Dipeptidyl Peptidase-4 (DPP-4) inhibitors like Sitagliptin, or Alpha-Glucosidase inhibitors like Acarbose and Miglitol, which do not interfere with bone healing.
- •The study includes individuals with a single bounded edentulous space, primarily in the lower posteriors (premolars and molars), with intact proximal teeth and sufficient bone quantity for implant placement.
- •Adequate bone height (at least 13mm) and bone width (at least 6mm) are required.
- •Eligible patients must be cooperative, motivated, and maintain good oral hygiene.
- •Additionally, participants should exhibit stable occlusion without parafunctional habits and have local factors present without signs of clinical inflammation.
- •This study is conducted under the supervision of the Institutional Review Board of SRM Dental College, Ramapuram.
排除标准
- •Patients with active periodontal disease, evidence of attachment loss greater than 1 to 2mm, or radiographic bone loss extending beyond the middle third of the adjacent teeth are excluded from the study.
- •Additional exclusion criteria include the use of antimicrobial agents within three months before the study, a diagnosis of systemic diseases other than type 2 diabetes mellitus, and bone disorders such as hyperparathyroidism, osteoporosis, or Paget’s disease.
- •Patients who have undergone steroid therapy, anti-inflammatory treatment, or bisphosphonate use within the past six months, as well as those treated with radiotherapy or chemotherapy, are not eligible.
- •Chronic alcoholics, smokers, and individuals with a history of drug abuse are excluded.
- •Pregnancy and lactation are also disqualifying factors.
- •Furthermore, patients who do not comply with the one-year follow-up requirement are excluded from the study.
结局指标
主要结局
and 1 year with standardized Intra oral periapical radiographs in Control
时间窗: Baseline and 1 year
(SLA) and Test groups (SLA-Active & LMGI).
时间窗: Baseline and 1 year
2. Implant survival rates (%) to be assessed at 1 year with radiographic
时间窗: Baseline and 1 year
Active & LMGI).
时间窗: Baseline and 1 year
1.Mean Crestal bone level changes (mm) to be assessed at Baseline
时间窗: Baseline and 1 year
and clinical assessment between Control (SLA) and Test groups (SLA-
时间窗: Baseline and 1 year
次要结局
- To evaluate and compare the Relative position of gingival margin (mm) at the implant site of Control (SLA) and Test groups (SLA Active and LMGI) at Baseline, 6 months and 1 year post loading.(baseline, 6 months and 1 year)
- 2.To assess the Implant stability quotient (ISQ) values using resonance frequency analysis (RFA) during Early Loading protocol.(3. To assess the Early Wound Healing Index (EWHI) using Huang et al index (2005) at the 1st week, 2nd week, and 4th week during the Early Loading protocol, comparing the Control (SLA) and Test groups (SLA ACTIVE & Laser Micro-Grooved Implants).)
研究者
研究点 (1)
Loading locations...
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