| CTRI Number |
CTRI/2025/09/095304 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of forward head posture with the risk of jaw joint disorders in 15–16-year-old school students. |
|
Scientific Title of Study
|
Association of Forward Head Posture with Risk of Temporomandibular Joint Disorders in 15–16-Year-Old School Students: A Cross-Sectional 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 |
Dr Zameera Naik |
| Designation |
Professor |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences,
Belgaum
KARNATAKA
590010
India |
| Phone |
9448854710 |
| Fax |
|
| Email |
drznaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zameera Naik |
| Designation |
Professor |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences,
KARNATAKA
590010
India |
| Phone |
9448854710 |
| Fax |
|
| Email |
drznaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra G |
| Designation |
Postgraduate student |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9677533351 |
| Fax |
|
| Email |
paviviji75@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE VK Institute of Dental Sciences, JNMC campus, Nehru nagar, Belagavi-590010 Karnataka-India. |
|
|
Primary Sponsor
|
| Name |
Dr Zameera Naik |
| Address |
Department of Oral Medicine and Radiology, KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education And Research, JNMC campus, Nehru nagar, Belgaum,Karnataka-590010, India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Zameera Naik |
St. Theresa English Convent School |
Hidkal Dam,
Belgaum
KARNATAKA |
09448854710
drznaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Willing participants with informed assent and parental consent. |
|
| ExclusionCriteria |
| Details |
1. Children with congenital craniofacial anomalies or skeletal deformities.
2. History of trauma to the head, neck, or face.
3. Ongoing or past orthodontic or orthognathic treatment.
4. Children with neuromuscular disorders or diagnosed psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of forward head posture — measured by craniovertebral angle less than or equal to 48 degree, assessed at baseline.
Presence of TMD — based on DC/TMD criteria and Fonseca’s Questionnaire score, assessed at baseline. |
Baseline-since its a cross-sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between severity of smartphone addiction & forward head posture
Gender distribution of FHP & TMD in the study population |
Baseline- since its a cross-sectional study |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
20/10/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Data Collection Procedure 1. Smart phone use evaluation will be done using The Smartphone Addiction Scale(2013) 1. Assessment of Forward Head Posture, by two Physiotherapists - Each participant will be asked to stand in their natural relaxed posture.
- Colored markers will be placed on anatomical landmarks: the tragus of the ear and the spinous process of the 7th cervical vertebra (C7).
- Lateral photographs will be taken from a fixed distance of 1.5 meters using a digital camera. Three times the photographs will be taken and a mean value will be considered.
- The craniovertebral angle (CVA) will be measured using digital software (Adobe Acrobat Reader or Posture Screen Mobile App).
- A CVA less than or equal to 48 degree will be considered indicative of forward head posture.
2. Assessment of Temporomandibular Disorders by a Dentist - TMD screening will be carried out using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I, including:
- Pain on palpation of the TMJ and masticatory muscles.
- Joint sounds (clicking, crepitus) during jaw movement.
- Limitations or deviations during mouth opening.
- Fonseca Questionnaire-based history of headaches, jaw locking, bruxism, or clenching.
|