| CTRI Number |
CTRI/2023/02/049900 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
to compare the age of bone with specific bone alkaline phosphate level present in saliva |
| Study Design |
Other |
|
Public Title of Study
|
To compare biomarkers present in the saliva with bone age |
|
Scientific Title of Study
|
Evaluation and Correlation of Salivary Bone-Specific Alkaline Phosphatase level with Skeletal age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Teisovinuo Kesiezie |
| Designation |
post graduate student |
| Affiliation |
Inderprasthaa Dental college and Hospital |
| Address |
Third Floor. Room number 2, Department of Orthodontics and
Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,
46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
06909825584 |
| Fax |
|
| Email |
faithgrace25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Yadav |
| Designation |
Professor |
| Affiliation |
Inderprasthaa Dental college and Hospital |
| Address |
Third Floor. Room number 2, Department of Orthodontics and
Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,
46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9212794482 |
| Fax |
|
| Email |
deepti.yadav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Teisovinuo Kesiezie |
| Designation |
post graduate student |
| Affiliation |
Inderprasthaa Dental college and Hospital |
| Address |
Third Floor. Room number 2, Department of Orthodontics and
Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,
46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
06909825584 |
| Fax |
|
| Email |
faithgrace25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental college and Hospital 46/1 Sahibabad Industrial Area, Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010 |
|
|
Primary Sponsor
|
| Name |
Dr Teisovinuo Kesiezie |
| Address |
Third Floor. Room number 2, Department of Orthodontics and
Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,
46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh |
| 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 Teisovinuo kesiezie |
Inderprastha Dental College & Hospital |
Third Floor. Room number 2, Department of Orthodontics and
Dentofacial Orthopaedics, Inderprastha Dental College and Hospital,
46/1 Site 4 Industrial Area Sahibabad Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH |
6909825584
faithgrace25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
• age group of 9–19 years,
• good general health, no nutritional issues
• good oral hygiene
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
• age group of 9–19 years,
• good general health, no nutritional issues
• good oral hygiene
|
|
| ExclusionCriteria |
| Details |
1.Individuals with systemic diseases that affect growth, such as Vitamin D metabolism disorders, parathyroid, growth and thyroid hormone disorders, renal impairment, and diabetes mellitus.
2.Individuals who have taken any medication that could affect bone metabolism in the last six months, such as vitamin preparations and calcium supplements.
3.Individuals who have had xerostomia in the past.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a correlation between bone alkaline phosphatase level and skeletal bone age. |
8 weeks and 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be a correlation between bone alkaline phosphatase level and skeletal bone age. |
5 weeks 2 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2023 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
skeletal maturity can have a significant impact on orthodontic diagnosis, treatment planning, treatment goal and the end result. There are several ways to assess skeletal maturity and one of the most popular methods is the hand and wrist radiograph maturity indices. Recently some biomarkers presented in saliva which are involved in bone formation and remodeling offer a newer possibility to measure the skeletal age. In various studies the levels of certain biomarkers such as the salivary alkaline phosphatase were considerably raised during pubertal phase. Therefore, this study is undertaken to evaluate and compare the level of salivary alkaline phosphatase level with skeletal age using hand and wrist radiographs. |