| 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
|
|
|
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
|
|
|
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. |