| CTRI Number |
CTRI/2021/03/032334 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
17/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of enlarged adenoids and tonsils with growth of jaws, teeth and breathing habit in 4-12 year old children |
|
Scientific Title of Study
|
Co-relation of Hypertrophic Adenoids and Tonsils with Craniofacial Growth, Occlusion and Breathing Habit in 4-12 Year Old Children |
| Trial Acronym |
HAT-CFG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidhi Jaiswal |
| Designation |
Post-Graduate student (MDS 1st year) |
| Affiliation |
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
| Address |
Department of pediatric and preventive dentistry
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be university,Pipariya, Waghodia
Vadodara
Vadodara
GUJARAT
390022
India |
| Phone |
02668245266 |
| Fax |
|
| Email |
vidhijaiswal42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
professor |
| Affiliation |
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
| Address |
Department of pediatric and preventive dentistry
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be university,Pipariya, Waghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
dranshula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshula Deshpande |
| Designation |
professor |
| Affiliation |
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
| Address |
Department of pediatric and preventive dentistry
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be university,Pipariya, Waghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
dranshula@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital, Sumandeep Vidyapeeth deemed to be university. |
|
|
Primary Sponsor
|
| Name |
Dr Vidhi Jaiswal |
| Address |
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth deemed to be university, Pipariya , Waghodia , Vadodara |
| 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 Vidhi Jaiswal |
Sumandeep Vidyapeeth |
Department of Pediatric and preventive dentistry (Dept No. 3), K M Shah Dental College and Hospital
Vadodara
GUJARAT |
9016613468
vidhijaiswal42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: (For cases-Group A)
1. The children between the age group of 4-12 years.
2. Children with hypertrophy of adenoids (value less than 1.0) or associated
to hypertrophy of palatine tonsils (grade 3 and 4) with signs of respiratory
obstruction.17,18
Page 15 of 58
3. The children whose parents will give the written informed consent and assent for study.
Inclusion criteria: (For controls-Group B)
1. The children between the age group of 4-12 years.
2. Children without hypertrophy of adenoids or palatine tonsils with no signs of respiratory obstruction.17,18
3. The children whose parents will give the written informed consent and assent for study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Children with history of maxillofacial trauma or surgery.
2. Children with cleft lip and cleft palate.
3. Children with systemic disease.
4. Children undergoing orthodontic treatment.
5. Children with mouth-breathing or Oro-nasal breathing habit. (for control group) |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To co-related the effect of hypertrophic Adenoids and Tonsils with Craniofacial Growth, Occlusion and Breathing Habit in 4-12 Year Old Children |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the effect of hypertrophic adenoids and tonsils with craniofacial growth and breathing habit in children in 4-12 years |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/04/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title "Co-relation of Hypertrophic Adenoids and Tonsils With Craniofacial Growth, Occlusion and Breathing Habit in 4-12 Year Old Children" Methodology - It is an observational cross-sectional study. 4 - 12 years old children reported to Dhiraj Hospital and K M Shah Dental College and Hospital, Sumandeep Vidhyapeeth(Deemed To Be University) diagnosed with Hypertrophy of adenoids (Value lower than 1.0) and Enlarged tonsils (Grade 3 And 4, According to Brodsky’s Classification) will be selected as cases. After obtaining written consent from parents and assent from children, study will continue further. The participants will be selected as per the inclusion and exclusion criteria. Children with hypertrophy of adenoids (value lower than 1.0) and tonsils (grade 3 and 4) will be regarded as group A(cases) and children without hypertrophy of adenoids and tonsils will be regarded as group B(controls). Selection of age-matched controls will be carried out after the selection of cases is completed.
Examination of each participant will be carried out as follows: 1. First the demographic details will be collected and entered in the proforma. 2. Parents will be asked in for the history pertaining to respiratory obstruction or infection and it will be recorded. 3. Extra-oral photographs will be taken and evaluated for facial profile, facial divergence, facial symmetry and lip posture. 4. Mirror test/Fog test will be performed for evaluation of the breathing habit. 5. Intra-oral examination will be done for evaluation of orthodontic parameters 6. Physical examination of the tonsils will be carried out 7. After clinical examination, a standardised lateral cephalogram will be taken 8. Hypertrophy of adenoids will be assessed by measuring airway-to-soft palate ratio on lateral cephalogram 9. Cephalometric analysis will be carried out to assess the growth pattern of maxilla and mandible.
Reference - 1] Valera FCP, Travitzki LVV, Mattar SEM, Matsumoto MAN, Elias, AM, & Anselmo-Lima, WT. Muscular, functional and orthodontic changes in pre school children with enlarged adenoids and tonsils. International Journal of Pediatric Otorhinolaryngology, 67(7), 761–770. |