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CTRI Number  CTRI/2025/04/086028 [Registered on: 30/04/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Bite registration and fabrication of reflex releasing diagnostic splint with mandibular position achieved with long phonetics 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Sanjay Sharma 
Designation  Professor 
Affiliation  Dr Ziauddin Ahmad Dental College and Hospital 
Address  Dept. of Preventive and Pediatric Dentistry, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments,
Aligarh
UTTAR PRADESH
202002
India 
Phone  09977701098  
Fax    
Email  drdivyassharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Divya Sanjay Sharma 
Designation  Professor 
Affiliation  Dr Ziauddin Ahmad Dental College and Hospital 
Address  Dept. of Preventive and Pediatric Dentistry, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments,

UTTAR PRADESH
202002
India 
Phone  09977701098  
Fax    
Email  drdivyassharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Divya Sanjay Sharma 
Designation  Professor 
Affiliation  Dr Ziauddin Ahmad Dental College and Hospital 
Address  Dept. of Preventive and Pediatric Dentistry, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments,

UTTAR PRADESH
202002
India 
Phone  09977701098  
Fax    
Email  drdivyassharma@gmail.com  
 
Source of Monetary or Material Support  
Dr Ziauddin Ahmad Dental College and Hospital, Aligarh Muslim University, Aligarh, 202002 
 
Primary Sponsor  
Name  Dr Divya Sanjay Sharma 
Address  Dept of Pediatric and Preventive Dentistry, Dr Ziauddin Ahmad Dental College and Hospital, AMU, Aligarh, 202002 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Sanjay Sharma  Aligarh Muslim University  Dept. of Pediatric and Preventive Dentistry, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh E-606, Greenpark Apartments, Quarsi Etah chungi bypass road, Aligarh, 202001
Aligarh
UTTAR PRADESH 
09977701098

drdivyassharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group patients (FMSH in transverse,anterior, posterior or complex plane)which will not be given the Reflex releasing diagnostic splint  The dental, skeletal, functional and postural effects of Reflex releasing diagnostic splint will be compared with the patients who has not been given Reflex releasing diagnostic splint for 8 weeks time period both pre and post.  
Intervention  Reflex releasing diagnostic splint with modified posterior occlusal plane  Reflex releasing diagnostic splint fabricated with modified posterior occlusal plane where bite would be registered at the centric relation position attained with the help of long phonetics. The dental, skeletal, functional and postural effects of Reflex releasing diagnostic splint will be compared with the patients who has not been given Reflex releasing diagnostic splint for 8 weeks time period both pre and post. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Patients with
age 5-11 years
Functional mandibular shift with CO-CR discrepancy in transverse, anterior, posterior or complex plane  
 
ExclusionCriteria 
Details  Patients with- no consent, craniofacial syndrome, skeletal malocclusion, receiving or previous history of orthodontic treatment, no systemic acute or chronic illness  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved maxillo-mandibular occlusal relation, Improved Condyle-fossa relation bilaterally, Improved bilateral chewing, Improved mandibular centric relation, improved head and neck posture   at T0 and 8 weeks post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 


 
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