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临床试验/CTRI/2026/02/103272
CTRI/2026/02/103272尚未招募4 期

Assessment of osteoblastic activity around dental implants following Low-Intensity Pulsed Ultrasound (LIPUS) therapy in patients with type 2 Diabetes Mellitus: A split-mouth randomised controlled trial

Sarvesh Kulkarni1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年3月12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
10
试验地点
1
主要终点
To asses the osteoblastic activity around dental implants in patients with Type 2 Diabetes Mellitus using bone scintigraphy

研究概览

简要总结

Diabetes mellitus was once considered a contraindication to the use of dental implant therapy, as it has been associated with comorbidities, including increased susceptibility to infection, impaired wound healing, and periodontitis. Since dental implants and techniques for controlling diabetes have evolved, dental implant therapy has become increasingly common among patients with Type 2 Diabetes Mellitus. The rising success of dental implants in prosthodontic rehabilitation has shifted current trends to accommodate Dental Implant placement in patients with controlled Type 2 Diabetes Mellitus. With advancements in implant surface treatment technology, Type 2 Diabetes Mellitus with well-controlled blood glucose levels is no longer considered an absolute contraindication for implant surgery. However, several studies have reported that patients with these diseases still pose a potentially high risk of implant failure. Various studies have indicated that patients with Type 2 diabetes mellitus exhibit diminished proliferation and osteogenic differentiation capabilities of osteoblasts compared to individuals without Type 2 diabetes mellitus. Also, elevated blood glucose levels can significantly impact bone tissue remodeling and interfere with the bonding between implants and bone, particularly within the first three weeks following implant placement. Literature suggests various methods to improve osseointegration around Dental Implants in patients with Type 2 Diabetes Mellitus, however effective and simple methods to enhance the osseointegration around Dental Implants are yet to be found. Abdulhameed et al. suggested a simple and effective method known as Low-Intensity Pulsed Ultrasound (LIPUS) therapy for effectively enhancing implant osseointegration and reduced healing duration. Low-Intensity Pulsed Ultrasound (LIPUS) is a noninvasive therapy that harnesses acoustic pulsed energy to provide physical stimulation. The use of LIPUS (Low-Intensity Pulsed Ultrasound Stimulation) has been shown to have a stimulatory effect on bone regeneration and osseointegration around dental implants.

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
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Partially edentulous participants with bilaterally missing mandibular posterior teeth willing for implant-supported prosthesis.
  • Patients aged between 21 to 60 years.
  • Patients with Controlled Type 2 Diabetes Mellitus (HbA1c level 5.7 to 8%).

排除标准

  • 未提供

结局指标

主要结局

To asses the osteoblastic activity around dental implants in patients with Type 2 Diabetes Mellitus using bone scintigraphy

时间窗: 30 days, 60 days, 90 days

次要结局

  • To asses the osteoblastic activity around dental implants in patients with Type 2 Diabetes Mellitus using Alkaline phosphatase (ALP) assay.(30 days, 90 days)
  • To asses the Patient Related Outcome Measures (PROMs) regarding the LIPUS therapy using Visual Analog Scale (VAS).

研究者

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

Sarvesh Kulkarni

Sri Ramachandra Dental College and Hospital

研究点 (1)

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