| CTRI Number |
CTRI/2025/08/093012 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
study on the effect of correcting bite problems on neck posture and neck muscle activity |
|
Scientific Title of Study
|
Comparison of cervical spine curvature, neck muscle activity and posture in individuals with normal occlusion versus those with sagittal malocclusions pre and post orthodontic assessment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Abichandani |
| Designation |
Principal Investigator and Prosthodontist |
| Affiliation |
silverline dent and care solutios pvt ltd |
| Address |
department of prosthodontics, silverline dent and care solutions , chembur, mumbai
Ashiyana plot no 105B first floor sindhi society chembur east mumbai - 400071
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Abichandani |
| Designation |
Principal Investigator and Prosthodontist |
| Affiliation |
silverline dent and care solutios pvt ltd |
| Address |
department of prosthodontics, silverline dent and care solutions pvt ltd, chembur, mumbai
Ashiyana plot no 105B first floor sindhi society chembur east mumbai - 400071
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Abichandani |
| Designation |
Principal Investigator and Prosthodontist |
| Affiliation |
silverline dent and care solutios pvt ltd |
| Address |
department of prosthodontics, silverline dent and care solutions pvt ltd, chembur, mumbai
Ashiyana plot no 105B first floor sindhi society chembur east mumbai - 400071
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9819700729 |
| Fax |
|
| Email |
sagar.abichandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| silverline dent and care solutions pvt ltd, sindhi society, chembur east, mumbai 400071 |
|
|
Primary Sponsor
|
| Name |
Silverline Dent ad Care Solutions |
| Address |
Ashiyana plot no 105B first floor sindhi society chembur east mumbai 400071 |
| Type of Sponsor |
Research institution |
|
|
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 sagar abichandani |
silverline dent and care solutions |
Ashiyana plot on 105B first floor sindhi society chembur east mumbai 400071
Mumbai
MAHARASHTRA |
9819700729
sagar.abichandani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trial Participant ICD Condition:
Sagittal Malocclusion (Class II / Class III) – ICD-10 Code: K07.1 (Anomalies of jaw-cranial base relationship)
Also mention Normal Occlusion (Control group) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Class II or Class III sagittal malocclusion (ANB angle more than 4 degrees for Class II, less than 0 degree for Class III) requiring orthodontic correction (study group).
Individuals with normal Class I occlusion, well aligned arches, no prior orthodontic treatment (control group).
Good general health without systemic illnesses.
Willing to provide informed consent and comply with radiographic, EMG, and posture evaluations pre- and post-treatment. |
|
| ExclusionCriteria |
| Details |
History of temporomandibular joint disorders, craniofacial anomalies, or cleft lip/palate.
• Neuromuscular disorders, cervical spine pathology, or postural deformities unrelated to occlusion.
• Prior orthodontic or prosthodontic treatment affecting occlusion.
• Chronic neck pain or recent cervical injury.
• Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in cervical spine curvature measured on lateral cephalometric radiograph
Change in neck muscle activity measured photogrammetrically
Change in head and neck posture measured using surface electromyography (EMG) |
baseline ( before orthodontic treatment)
at 6 months after initiation of treatment
at completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between type/severity of malocclusion (Class II or III) and cervical posture parameters
• Improvement in forward head posture (craniovertebral angle) post-orthodontic treatment relative to controls
• Relationship between EMG changes and radiographic posture changes |
Same as primary: baseline and post-treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="1"
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
|
This observational case-control study aims to evaluate the relationship between dental occlusion and cervical spine posture. Sixty participants will be recruited, including thirty individuals with normal Class I occlusion and thirty individuals with sagittal malocclusions classified as Class II or Class III. Baseline assessments will include lateral cephalometric radiographs for cervical spine curvature, surface electromyography of sternocleidomastoid and upper trapezius muscles, and photogrammetric analysis of craniovertebral angle to assess forward head posture. Malocclusion participants will undergo standard orthodontic treatment to correct their bite and will be reassessed after treatment completion. The study will compare pre and post treatment posture changes within the malocclusion group and also compare these findings with control subjects. The primary objective is to determine whether orthodontic correction leads to improvement in cervical posture and muscle activity. Findings may have implications for integrating postural considerations in orthodontic and prosthodontic treatment planning.
|