| 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
|
|
|
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. |