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临床试验/CTRI/2024/10/075696
CTRI/2024/10/075696尚未招募4 期

An evaluation of periimplant tissues with and without application of 1 percent metformin gel on dental implant surface and in osteotomy site during implantation A Randomized clinical controlled trial

Dr Geeta Bhutda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月25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
30
试验地点
1
主要终点
Cresta bone level change

研究概览

简要总结

Modern dentistry aims to restore the oral health of patients in a predictable fashion. Depending on an individual’s local, environmental, physiological, mental, and financial status, the lost teeth are replaced with the best possible alternative.The use of dental implants for treating complete or partial edentulism is a widely accepted treatment option as a result of its high rate of success. Metformin is an oral biguanide antidiabetic drug. It is a commonly used medication administered to patients with DM2, polycystic ovarian syndrome, and metabolic syndrome. Metformin improves periodontal health by controlling blood sugar levels and increasing the outcomes of periodontal therapy. More recent studies have indicated that it may have a direct antiresorptive effect on periodontal bone. Metformin inhibits bone resorption by reducing receptor activator of nuclear factor kappa B ligand (RANKL) expression and increasing osteoprotegerin (OPG) expression. Enhancing osteoblast proliferation and reducing osteoclast activity are two possible mechanisms of action for metformin’s osteogenic impact. Given its capacity to regulate blood glucose levels and promote bone repair, investigating the potential of metformin (MF) in bone physiology holds significant value. The potential application of metformin as an adjunct to dental implants could offer novel insights into bone physiology. The impact of locally applying metformin to the implant surface during implantation has not been extensively studied in the literature, so the aim of this study is to evaluate the clinical and radiographic effectiveness of 1% metformin gel when applied over the implant surface and at the osteotomy site.

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 and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Both genders.
  • Subjects with ages ranging from 18 to 75 years.
  • Partially edentulous subjects and wants to replace their missing teeth.
  • Systemically healthy subjects without having any medical illness that can impact the surgical protocol.
  • (ASA Grade 1 or 2).
  • Patients sign a written consent form.

排除标准

  • Subjects with uncontrolled diabetes Subjects with poor oral hygiene.
  • {Plaque Index (PI) ≥1} Pregnant and lactating females.
  • Subjects who are alcoholics Patients who are using bisphosphonates Subjects with severe clenching and grinding (parafunctional habits) Active infection or severe inflammation at the planned implant site Physically handicapped and mentally disabled subjects.
  • Patient with history of bone augmentation surgery Participants had known allergies to the drugs used for the study.

结局指标

主要结局

Cresta bone level change

时间窗: At implant placement, at implant uncovery and | and 3 months post prosthetic delivery

次要结局

  • Stability of bucco-lingual dimensions at baseline(and 3 months post prosthetic delivery.)
  • Bone density using Cone Beam Computed Tomography(3 months after prosthetic delivery.)

研究者

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

Dr Vishnudas Bhandari

Maharashtra Institute of Dental Sciences and Research dental college Latur.

研究点 (1)

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