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CTRI Number  CTRI/2025/04/085106 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Pilot study 
Study Design  Single Arm Study 
Public Title of Study   Long Phonetic method for correction of lower jaw position in children 
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  NILL 
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 and Hospital, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments, Quarsi Etah chungi bypass road, Aligarh, 202001
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 and Hospital, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments, Quarsi Etah chungi bypass road, Aligarh, 202001
Aligarh
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 and Hospital, Aligarh Muslim University, Aligarh
E-606, Greenpark Apartments, Quarsi Etah chungi bypass road, Aligarh, 202001
Aligarh
UTTAR PRADESH
202002
India 
Phone  09977701098  
Fax    
Email  drdivyassharma@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Mechanical Engineering, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, 202002 
Dr Ziauddin Ahmad Dental College and Hospital, Aligarh, Muslim University, Aligarh, Uttar Pradesh, India, 202002 
 
Primary Sponsor  
Name  Dr Divya Sanjay Sharma 
Address  Dept. of Pediatric and Preventive Dentistry, Aligarh Muslim University, Aligarh, Uttar Pradesh, 202002 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Prof Abid Ali Khan  Dept of Mechanical Engineering, Jakir Husain College of Engineering and Technology, Aligarh Muslim University, Aligarh 
Prof Sandhya Maheshwari  Dept. of Orthodontics and Dentofacial Orthopedics, Dr. Ziauddin Ahmad Dental College and Hospital, Aligarh Muslim University, Aligarh 
 
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. Pediatric and Preventive dentistry, Dr Ziauddin Ahmad Dental College and Hospital and Dept. of Mechanical Engineering Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH 
09977701098

drdivyassharma@gmail.com,  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, U.P., 202002NMC  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 
Intervention  NILL  NILL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Patients with
age 5-10 years
functional mandibular shift with CO-CR discrepancy 
 
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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Getting symmetric bilateral activity of masseter and anterior temporalis muscles denoting correct centric relation of mandible clinically  before and after long phonetic exercise for approximate 5-10 minutes both at rest and clenching  
 
Secondary Outcome  
Outcome  TimePoints 
improvement in facial proportions and proper condylar seating in glenoid fossa   Before and after long phonetic exercise for approximate 5-10 minutes  
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   30/04/2025 
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="0"
Months="6"
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  

Symmetric bilateral activity of masticatory muscle has been considered to keep mandible in centric relation (CR) to cranium.  This is the physiological rest position of mandible which while stomatognathic functions (speech, respiration, mastication etc.) provide symmetric proprioception and in turn promote balance growth of facial skeleton including components of temporomandibular joint (TMJ) bilaterally. However, mandible while occluding tends to reach in maximum intercuspation position (MIP). If MIP is achieved in without much deviation of mandible as that of centric relation, called as centric occlusion (CO) with unstrained position of TMJ and symmetrical tonicity and activity of associated muscles. However, many times premature contacts (PC) because of environmental causes in deciduous or in mixed dentition, may deviate mandible to the position other than ideal CO known as CO-CR discrepancy or Functional mandibular shift (FMSH). FMSH in transverse/ coronal plane are clinically evident as unilateral posterior crossbite (UPXB), while that of in sagittal plane as pseudo-class III or developing Class II.

To differentiate between skeletal and functional malocclusion, a clinician needs to bring mandible in CR and then to closely observe closing path of mandible to find premature contact responsible for function shift. Some conventional qualitative methods to achieve CR are- swallowing with tongue tip at incisive papilla, phonetics with word ‘Mississippi’. Electromyographic studies found that jaw movements are quickly learned and UPXB may persist even at rest position ready to occlude in MIP. While similar muscular activity was found when mouth was opened wide. Other quantitative methods eg. Transcutaneous Electrical Nerve Stimulation (TENS), Electromyography (EMG), Jaw tracing device and T-Scan are getting popularity in Neuromuscular dentistry (NMD) set up now a days. All these methods are applied in patients with known temporomandibular disorders. Researches could find 50% correction only of centric relation in patients with FMSH. Firstly, because not guaranteed results and also for being expensive these methods cannot be applied in fields or routine clinical checkup. Secondly if machine gets corrupted, its repair is usually time consuming and expensive both.

 The phonetics ‘Mississippi’ does not help mandible open wide. In prosthodontics it relocates mandible for minimum required vertical opening while function of speech. Therefore, this word is denoted here as ‘short phonetics’.

Some new words are searched i.e. Aam, Raam and Naam (denoted as long phonetics) to facilitate little children pronounce easily. The vowel ‘Aa’ helps open mouth wide stretching bilateral muscles and breaking the faulty proprioception from PDL and muscle itself. The consonants ‘R’ and ‘N’ help tongue to touch incisive papilla on palate thereby helping transverse maxillo-mandibular relation. The consonant ‘M’ is the bilabial sound, helps bringing mandible in sagittal and vertical alignment. According to Devnagari varnmala these innovative words include ‘Swara’ the first sound to start, to the last group of bilabial sound. Words are popular in India and easy to memorize by children.

Therefore, the study aimed to validate the effect of long phonetic method to get mandibular centric relation by quantifying bilateral activity of muscles of mastication both pre-phonetics and after phonetics with the help of surface EMG method. Once it is validated, the long phonetics can be applied in clinics and field studies without use of cumbersome machines.

 
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