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临床试验/CTRI/2025/04/086028
CTRI/2025/04/086028尚未招募不适用

Evaluation of dental, skeletal, functional, and postural changes pre and post neuro-occlusion rehabilitation with reflex releasing diagnostic splint in children with functional mandibular shifts with deciduous and early mixed dentition- A case control study

Dr Divya Sanjay Sharma1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Improved maxillo-mandibular occlusal relation, Improved Condyle-fossa relation bilaterally, Improved bilateral chewing, Improved mandibular centric relation, improved head and neck posture

研究概览

简要总结

Functional mandibular shifts (FMSH) and occlusion in any plane (transeverse, anterior, posterior or complex) tends to become habitual because of constant neural feedback from proprioceptive receptors situated in periodontal membrane to the brain.

This neural feedback, if not broken at early age, the bony changes in TMJ, and/or maxilla and mandible may become skeletal deformity with age advancement, treating which becomes increasingly difficult task.

A good balance of masticatory and head and neck muscles seems to be an important factor of postural stability.

No improvement was found in posture in sagittal plane malocclusions when patients were in adult age (18 - 52 years) with permanent dentition.

Moreover, true anterior, posterior and lateral FMSH have been studied extensively but FMSH occurring because of the factors arise during complex changes in deciduous and early mixed dentition have not been researched yet.

Functional occlusion shifts with altered condylar spatial articulation in glenoid fossa has potential to modify TMJ morphology, mandibular asymmetry, asymmetric muscle activity, which are minor in pediatric patients but become aggravating problem with age progression.

Palatal and/or dental expansion has been studied extensively for functional unilateral crossbite (UPXB) cases. Researchers treated UPXB patients with expansion and could achieve complete crossbite elimination in 50% of the cases only. Asymmetric posterior occlusion remained prevalent in treated cases. Also, reverse sequencing was reduced but not eliminated post-treatment.

On the other hand, patients in mixed dentition age, treated with reflex releasing occlusal splint in removable palatal expander showed complete elimination of UPXB and midline shifts along with symmetric spatial location of condyles in glenoid fossa. Similar stable results were found when neuro-occlusion was established in patients (3-6 years) with planas direct tracks and selective grinding. There was self-correction of maxillary arch constriction in these patients.

It seems evident that neuro-occlusion rehabilitation alone before 6 years of age and prior to expansion in mixed dentition age group results in stable CO-CR synchronicity.

Whether breaking the eccentric proprioception and neural feedback with reflex releasing diagnostic splint in all the FMSH cases be it in any plane as described above, would bring mandible in neuro-occlusion, still remain a dilemma.

Secondly reflex releasing splints serve as diagnostic tools to prove developing malocclusion as functional that some environmental factors are acting on teeth, bone, muscle system. However, studies are very limited to validate this hypothesis.

No study could be found correlating effect of neuro-occlusion establishment on dental, skeletal and posture altogether.

Therefore, the aim of this study is to assess dental, functional, postural and skeletal changes pre and post neuro-occlusion rehabilitation using diagnostic reflex releasing splint in children with deciduous and early mixed dentition with functional shift of mandible.

Null hypothesis is that there is no effect of diagnostic reflex releasing splint on dental, skeletal, functional, and posture in patients with functional mandibular shift.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • •Patients with age 5-11 years Functional mandibular shift with CO-CR discrepancy in transverse, anterior, posterior or complex plane.

排除标准

  • •Patients with- no consent, craniofacial syndrome, skeletal malocclusion, receiving or previous history of orthodontic treatment, no systemic acute or chronic illness.

结局指标

主要结局

Improved maxillo-mandibular occlusal relation, Improved Condyle-fossa relation bilaterally, Improved bilateral chewing, Improved mandibular centric relation, improved head and neck posture

时间窗: at T0 and 8 weeks post operatively

次要结局

未报告次要终点

研究者

发起方
Dr Divya Sanjay Sharma
申办方类型
Other [self]

研究点 (1)

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