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临床试验/NCT05313399
NCT05313399Unknown3 期

Skeletal and Dentoalveolar Effects of Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: A Randomised Clinical Trial.

Reem Hatem Shams0 个研究点目标入组 30 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
30
主要终点
Overbite distance correction in millimeter

研究概览

简要总结

The study evaluates the effects of palatal crib versus bonded spurs in the early treatment of anterior open bite caused by non-nutritive sucking habits.

详细描述

Habit is an unintentionally performed repeated activity. Development of habit is considered a part of the natural progression of maturation in children between infancy and three years of age, after this period, it is assumed to be unnatural. The most familiar and earliest noted habit is thumb sucking. It develops during infancy as a rooting reflex, after it ceases around three years of age .

Thumb sucking is defined as the placement of the thumb or one or more fingers in different depths into the mouth ). It emerges in two forms: nutritive and non-nutritive, where the first gives nourishment and the second implements a sense of security and amenity. It is common in children and is reported to be harmless for up to five years of age .

There is an association between the habit of thumb sucking and the development of skeletal open-bite among children. Anterior open bites (AOBs) are defined as an occlusion in which the lower incisors are not overlapped in the vertical plane by the upper incisors and do not occlude with them when the posterior teeth are in maximum intercuspation . Anterior open bite due to thumb sucking, and a secondary tongue thrust exaggerates the condition . If identified early, this can be avoided and appropriate treatment is delivered.

Approaches for habit intervention include counseling, positive reinforcement, a calendar with rewards, an adhesive bandage, bitter nail polish, long sleeves, and appliance therapy. It is recommended to start with the least invasive methods before using habit-breaking appliances. Habit-breaking appliances are either fixed or removable. Fixed appliance therapy may be considered after the age of 4 years. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers . The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors. Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with nonnutritive sucking habits and/or tongue thrusting from 6 years to 11 years old.
  • Angle Class I malocclusions.
  • Anterior open bite equal to or greater than 1 mm.
  • Maxillary and mandibular permanent central incisors fully erupted (children in the first transitional period were eligible for treatment when the maxillary lateral incisors were beginning to erupt, and the maxillary central incisors were still showing an open bite).

排除标准

  • Children with loss of permanent teeth.
  • Crowding, maxillary constriction, or posterior crossbites.
  • Previous orthodontic treatment.
  • Presence of craniofacial anomalies or syndromes.
  • Tooth agenesis.

结局指标

主要结局

Overbite distance correction in millimeter

时间窗: 12 months

Digital dental model will be scanned using medit software to detect the changes that occur in the vertical distance ( in millimeter ) between incisal edges of the most erupted maxillary and mandibular central incisors in relation to the occlusal plane.

次要结局

  • Patient acceptance(1 month)
  • Changes in maxillary mandibular plane angle(12 months)

研究者

发起方
Reem Hatem Shams
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reem Hatem Shams

Master Student

Cairo University

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