Assessing the Effect of Exogenous Melatonin on The Stability of Orthodontic Mini-Implants: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Implant stability will be evaluated using insertion torque and resonance frequency analysis as primary outcome
研究概览
简要总结
AIM:
The study aims to evaluate the effect of topical administration of melatonin on the stability of orthodontic mini-implants through a Randomized controlled clinical trial.
Research question:
Does the topical administration of melatonin have any effect on the stability of orthodontic mini-implants?
Hypothesis:
The topical administration of melatonin has a significant effect on the stability of orthodontic mini-implants.
The topical administration of melatonin significantly reduces implant migration in orthodontic mini-implants.
The topical administration of melatonin has a significant impact on reducing pain perception during treatment with orthodontic mini-implants.
Null Hypothesis:
The topical administration of melatonin does not have a significant effect on the stability of orthodontic mini-implants.
The topical administration of melatonin does not significantly reduce implant migration in orthodontic mini-implants.
The topical administration of melatonin does not have a significant impact on reducing pain perception during treatment with orthodontic mini-implants.
P: Patients with average growth patterns, class I bimaxillary cases with upper first premolar extraction.
I: Topical melatonin application over the mini implant.
C: Placebo application over the mini implant.
O: Implant stability, Implant migration, and pain perception.
S: The sample size is 20
Experimental Group: Topical melatonin administration + mini-implant
Control Group: Placebo (matching appearance) + mini-implant
Based on the inclusion and exclusion criteria the Orthodontic patients requiring mini-implants for anchorage support will be selected in this study.
The primary objective is to evaluate implant stability through insertion torque and resonance frequency analysis. The secondary outcomes include assessing implant migration and pain perception among participants.
Throughout the treatment period, patients will undergo orthodontic procedures, including bracket placement and wire adjustments. TADs will be inserted and data collected at specific intervals.
Data collected will be tabulated and statistically analyzed.
This study holds a non-invasive adjunctive approach to optimize mini-implant stability and treatment outcomes. If proven effective, exogenous melatonin could become a valuable addition to the orthodontic armamentarium, by enhancing anchorage support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients requiring orthodontic treatment involving the placement of mini implants for anchorage support.
- •Patients with average growth patterns, class I bimaxillary cases with upper first premolar extraction, and space closure will be selected to standardize the cases.
- •Young adults aged 15-25 years old will be selected.
排除标准
- •Patients with known sleep cycle disturbances, metabolic bone disorders to melatonin will be excluded.
- •Pregnant or lactating individuals, as melatonin administration may affect pregnancy outcomes or breast milk composition.
- •Patients who have used melatonin supplements 3 months before the study Patients with active ongoing orthodontic treatment with Poor oral hygiene will be excluded which will lead to implant failure.
- •Patients unable or unwilling to attend scheduled follow-up visits will be excluded.
结局指标
主要结局
Implant stability will be evaluated using insertion torque and resonance frequency analysis as primary outcome
时间窗: insertion torque value measured at the time of insertion and Resonance Frequency Analysis (RFA) measurements will be taken | At the time of mini-implant placement(T1), | One month after mini-implant placement as (T2), | Two months after mini-implant placement (T3), | Three months after mini-implant placement (T4
次要结局
- The implant migration and pain perception will be evaluated as secondary outcome(Implant migration data will be collected from the lateral cephalogram)