跳至主要内容
临床试验/CTRI/2021/05/033887
CTRI/2021/05/033887尚未招募不适用

“Comparative evaluation of occlusal plane parallelism at different levels of ala tragus lines in dentulous patients-An in vivo study.â€

Dr Jay Dineshbhai Patel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月6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
100
试验地点
1
主要终点
The expected outcome for the present study would be in dentulous subjects the line drawn from the ala of the nose to the inferior part of the tragus will be relatively parallel to occlusal plane both in lateral cephalogram and lateral profile photograph.

研究概览

简要总结

Precise orientation of the occlusal plane plays a vital role inproviding optimal aesthetic, phonetics and mastication. It has been a great deal ofcontroversy regarding the anatomic reference point taken in identifying ala-tragus lineto which the occlusal plane is oriented parallel while making complete denture.Thus,The Purpose of the study is to determine accurately the part of tragus to be used to form the ala-tragusline or camper’s line while establishing the occlusal plane in edentulous patients usingphotographic and cephalometric methods.A total of 100 subjects will be selected for the study. In firststage, for photographic analysis Photographs will be taken with the subject standing intheir natural head position. Then, fox bite plane will be placed in the mouth in such aposition that it touched the incisal edges of the maxillary incisors and the cusps of theleft and right maxillary first molar. The plane will be held in the position by pressurefrom the opposing teeth. The outer wing of the plane indicates the position of theocclusal plane and these are readily seen in the photographs. The dots on superior(T1), middle (T2) and inferior (T3) margins of the right tragus, lower point of ala ofnose (A) and Orbital point (O) will be directly placed on the photo in computer. Insecond stage, for cephalometric analysis- Three points will be identified on tragus of earas superior (T1), middle (T2) and inferior (T3). The stainless-steel balls (3 mm indiameter) will be fixed at these selected points and also both at the lowest point of theala of the nose(A) and the lowest point on the inferior border of bony orbit (Or) withfine quality double sided adhesive tape to ensure perfect placement to capture therecording on cephalographs. Statistical Analysis: The statistical analysis will be carriedout using Descriptive analysis (mean, standard deviation, CI), independent T test andpaired T-test. Total 100 (50 male and 50 female) participants for the present studywill be selected to estimate mean difference in angles by 1.65 degree with standarddeviation of 3.2 at 95% confidence and 80% power.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Age group of 18 40 years By 18 years growth of the face ceases and there is no change in the relationship of campers plane to the occlusal plane The upper age limit was restricted to 40 years as at this age a dentition can be expected to remain normal without tooth loss and excessive attrition Straight or orthognathic profile For the ease of the comparison of the angulations Subjects should have regular alignment of teeth without any supra eruption or drifting ie well formed occlusion Subjects should have complete dentition of 24 teeth occlusal plane will be considered from the incisal edges of the upper central incisor to cusps of first molar A minimum of conservative treatment and that must not affect the occlusion plan.

排除标准

  • Previous history of orthodontic treatment Congenitally missing or extracted teeth Subjects should not have crowns fixed or removable partial dentures or supernumerary teeth or retained teeth Subjects with deciduous teeth Congenital or acquired defects in the head region Advanced periodontal diseases and associated tooth mobility TMJ disorder.

结局指标

主要结局

The expected outcome for the present study would be in dentulous subjects the line drawn from the ala of the nose to the inferior part of the tragus will be relatively parallel to occlusal plane both in lateral cephalogram and lateral profile photograph.

时间窗: Baseline.

次要结局

  • There will be no significant difference found between angle measured on lateral cephalogram and profile photograph as well as no influence of gender on the selection of part of tragus for ala-tragus line.(Baseline.)

研究者

发起方
Dr Jay Dineshbhai Patel
申办方类型
Other [myself]

研究点 (1)

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