| CTRI Number |
CTRI/2025/01/079532 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing one of chemical mediator of the orthodontic tooth movement in different blood groups. |
|
Scientific Title of Study
|
Comparison of alkaline phosphatase activity in gingival crevicular fluid during orthodontic tooth movement among different ABO blood group phenotypes. |
| 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. Jakshmi K J |
| Designation |
Junior Resident Post Graduate Student |
| Affiliation |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7034797705 |
| Fax |
|
| Email |
kjjakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jakshmi K J |
| Designation |
Junior Resident Post Graduate Student |
| Affiliation |
FACULTY OF DENTAL SCIENCES, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7034797705 |
| Fax |
|
| Email |
kjjakshmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jakshmi K J |
| Designation |
Junior Resident Post Graduate Student |
| Affiliation |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7034797705 |
| Fax |
|
| Email |
kjjakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Jakshmi K J |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 |
| 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 Vipul Kumar Sharma |
FACULTY OF DENTAL SCIENCES,INSTITUTE OF MEDICAL SCIENCES |
Room No. 3, Division of Orthodontics and Dentofacial orthopaedics
Varanasi
UTTAR PRADESH |
9389460640
vipulk.sharma1@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of alkaline phosphatase activity in different blood groups at intervals of 24hrs, 7 days, 14 days and 28 days after application of orthodontic force. |
Measuring alkaline phosphatase levels during orthodontic tooth movement in gingival crevicular fluid in different blood groups at intervals of 24hrs, 7 days, 14 days and 28 days after application of orthodontic force. |
| Comparator Agent |
Evaluation of alkaline phosphatase activity in different blood groups during orthodontic tooth movement at intervals of 24hrs, 7 days, 14 days and 28 days after start of force application. |
Measuring alkaline phosphatase levels during orthodontic tooth movement in gingival crevicular fluid in different blood groups at intervals of 24hrs, 7 days, 14 days and 28 days after start of orthodontic force application. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
permanent dentition.
requiring 1st premolar extraction.
good periodontal health.
no history of systemic diseases. |
|
| ExclusionCriteria |
| Details |
active periodontal disease
systemic disease or syndromes
long term inflammatory diseases or conditions.
parafunctional habits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| level of alkaline phosphatase level in different blood groups during orthodontic orthodontic tooth movement. |
Measured at 24hrs, 7 days, 14 days, 21 days and 28 days interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| detects any difference in biological response to orthodontic force in different blood groups. |
recorded at 24hrs, 7 days, 21 days and 28 days interval |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/02/2025 |
| 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="0"
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
|
In orthodontic treatment, there are two types of patients: responsive and non-responsive. Even with the application of same biomechanics, some patients respond faster and other patients respond slower. So, the rate of orthodontic treatment in individuals always remained a controversy. The rate of orthodontic tooth movement is ultimately determined by the levels of biomarkers released during orthodontic force application. Recently, genetic studies have provided evidence of interactions between ABO blood group antigen and fucosyl transferase genes on serum alkaline phosphatase levels. Moreover, FUT1 gene encodes α (1, 2)-fucosyl transferases, which is responsible for the synthesis of H antigens. Based on ALP activity in different blood groups, this study may revolutionize orthodontic therapy and its practice in the future. |