| CTRI Number |
CTRI/2020/03/024048 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of correlation between radiographs and salivary alkaline phosphatase levels as skeletal maturity indicators |
|
Scientific Title of Study
|
Evaluation of correlation between cervical vertebral maturation, hand-wrist radiographs and salivary alkaline phosphatase levels as indicators for skeletal maturity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr LINGANNAGARI SWATHI |
| Designation |
Research assistant |
| Affiliation |
Kamineni institute of dental sciences |
| Address |
Kamineni institute of dental sciences sreepuram narketpally nalgonda district
Nalgonda
TELANGANA
508254
India |
| Phone |
8328450768 |
| Fax |
|
| Email |
swathilingannagari17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M PAVAN KUMAR |
| Designation |
PROFFESOR |
| Affiliation |
Kamineni institute of dental sciences |
| Address |
Kamineni institute of dental sciences sreepuram narketpally nalgonda district
Nalgonda
TELANGANA
508254
India |
| Phone |
9959918080 |
| Fax |
|
| Email |
pavan.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LINGANNAGARI SWATHI |
| Designation |
Research assistant |
| Affiliation |
Kamineni institute of dental sciences |
| Address |
Kamineni institute of dental sciences sreepuram narketpally nalgonda district
Nalgonda
TELANGANA
508254
India |
| Phone |
8328450768 |
| Fax |
|
| Email |
swathilingannagari17@gmail.com |
|
|
Source of Monetary or Material Support
|
| kamineni institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Dr LINGANNAGARI SWATHI |
| Address |
Kamineni institute of dental sciences sreepuram narketpally nalgonda district |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| LINGANNAGARI SWATHI |
department of orthodontics and dentofacial orthopaedics |
Kamineni institute of dental sciences
Nalgonda
TELANGANA |
8328450768
swathilingannagari17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KIDS Narketpally |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
all classes of malocclusion |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Subjects in the age group of 8-16 years females will be selected who require orthodontic therapy
Good general health with absence of any nutritional problems
|
|
| ExclusionCriteria |
| Details |
Any subject diagnosed with a medical condition systemic disease salivary gland disorders will be excluded
Individuals under any medication that could affect bone metabolism during the previous 6 months for example vitamin preparations and calcium supplements
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alkaline phosphatase levels in saliva by Calorimetry |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
cervical vertebral maturation stages from lateral cephalograms
handwrist radiographs |
baseline |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/05/2020 |
| 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="5"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Skeletal maturity assessment plays a key role in
orthodontic diagnosis and treatment planning which is commonly done using
radiographic methods like cervical vertebral maturation and hand-wrist
radiographs, which involves additional radiation exposure.
New
noninvasive analysis of biological mediators such as insulin-like growth
factor-1 (IGF-1), salivary alkaline phosphatase (ALP), have been investigated
to assess skeletal maturity. Further studies have been recommended to
investigate the role of these biomarkers in assessing growth status. Hence
the present study is taken up to evaluate if salivary alkaline phosphatase
levels can be used to
assess skeletal maturity |