| CTRI Number |
CTRI/2025/08/093886 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the relation between ABO blood group Lipid profile CBC Vitamin D level CRP and biomarkers levels in Class I II III malocclusion patients to understand their systemic nature. |
|
Scientific Title of Study
|
Comprehensive Analysis of ABO Blood Groups Metabolic Profiles and Biomarker Dynamics in Malocclusion Patients : 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 Sakshee Nagvanshi |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Unit of Orthodontics and Dentofacial Orthopedics Faculty of Dental Sciences Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7985069581 |
| Fax |
|
| Email |
NAGVANSHISAKSHI@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TP Chaturvedi |
| Designation |
Senior Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Unit of Orthodontics and Dentofacial Orthopedics Faculty of Dental Sciences Institute of Medical Sciences Banaras Hindu University, Varanasi
BANARAS HINDU UNIVERSITY, LANKA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451570848 |
| Fax |
|
| Email |
drtpchaturvedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TP Chaturvedi |
| Designation |
Senior Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Unit of Orthodontics and Dentofacial Orthopedics Faculty of Dental Sciences Institute of Medical Sciences Banaras Hindu University, Varanasi
BANARAS HINDU UNIVERSITY, LANKA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451570848 |
| Fax |
|
| Email |
drtpchaturvedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF MEDICAL SCIENCES BANARAS HINDU UNIVERSITY |
| Address |
FACULTY OF DENTAL SCIENCES
INSTITUTE OF MEDICAL SCIENCES BHU
LANKA 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Sakshee Nagvanshi |
Faculty of Dental Science |
Unit of Orthodontics and Dentofacial Orthopedics Faculty of Dental Sciences Institute of Medical Sciences Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
7985069581
nagvanshisakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with different class of malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate and provide informed consent.Patients aged 18–30 years. Patients with a regular lifestyle pattern.Diagnosed with malocclusion classified as Class I, Class II, or Class III based on Angle’s classification. No prior orthodontic treatment or ongoing therapy.
6 Healthy individuals without systemic diseases that might affect serum biomarker levels.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Patients unwilling to participate.Individuals with a history of metabolic or endocrine disorders (e.g. diabetes hyperthyroidism). Pregnant or lactating women.
Use of medications influencing metabolic, inflammatory markers (e.g. corticosteroids, immunosuppressants) or any drug leading to periodontal condition leading to malocclusion. Participants with acute or chronic infections at the time of sample collection. Smoking or alcohol abuse history.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ABO Blood group Lipid profile CBC cortisol CRP Vitamin D and CTX-1, osteocalcin levels |
at the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/09/2025 |
| 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="6"
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
|
This cross-sectional study investigates the possible associations between ABO blood groups, systemic metabolic markers, and biomarker dynamics in individuals with different classes of malocclusion. The study will recruit 88 orthodontic patients (aged 18–30 years) visiting the Orthodontics and Dentofacial Orthopaedics outpatient department at the Faculty of Dental Sciences, IMS-BHU. The study aims to evaluate the distribution of ABO blood groups among malocclusion types and to examine lipid profiles, vitamin D levels, inflammatory markers (CRP, cortisol), and bone-related biomarkers (osteocalcin, parathormone, CTX-1) using blood samples. ELISA and standard hematological techniques will be used for analysis. By integrating genetic (blood group), metabolic, and biochemical data, the research aims to uncover systemic influences on malocclusion development and progression. This may contribute to early identification of at-risk individuals, promote personalized orthodontic treatment planning, and open new perspectives for preventive interventions targeting underlying systemic imbalances. |