| CTRI Number |
CTRI/2024/04/065636 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the effect of vitamin D levels on bone changes in the mouth of young adults undergoing braces treatment |
|
Scientific Title of Study
|
A comparative evaluation of effect of vitamin D status on orthodontic bone remodelling using biomarkers in gingival crevicular fluid among young adults seeking orthodontic treatment- an in-vivo 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 Ayushi Toley |
| Designation |
Post Graduate Student |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 6, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9595372181 |
| Fax |
|
| Email |
ayushitoley8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Javed Sodawala |
| Designation |
Professor and Head of the Deparment |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 6, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000858658 |
| Fax |
|
| Email |
drjavedazher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Toley |
| Designation |
Post Graduate Student |
| Affiliation |
Chhattisgarh dental college and research institute |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 6, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9595372181 |
| Fax |
|
| Email |
ayushitoley8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441 |
|
|
Primary Sponsor
|
| Name |
Dr. Ayushi Toley |
| Address |
Department of orthodontics and dentofacial orthopedics, room no 6, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Toley |
Chhattisgarh dental college and research institute |
Department of orthodontics and dentofacial orthopedics, room no 6, Chhattisgarh dental college and research institute, Sundra, Rajnandgaon, Chhattisgarh, India. Pincode- 491441
Rajnandgaon
CHHATTISGARH |
9595372181
ayushitoley8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh dental college and research institute |
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 |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with no gross skeletal dysplasia.
2. Patients with Angles Class I malocclusion with bimaxillary protrusion and minimal or no crowding requiring fixed orthodontic treatment indicated for bilateral maxillary first premolar extraction.
3. Fully erupted set of permanent dentition except third molars. |
|
| ExclusionCriteria |
| Details |
1. Patients requiring treatment with functional jaw orthopedics or orthognathic surgery.
2. Presence of craniofacial anomalies.
3. presence of any signs and symptoms of gingival and periodontal diseases.
4. Presence of significant medical history and medication known to affect the normal bone remodeling process like chemotherapy, radiation therapy, hormonal replacement therapy or bisphosphonate therapy, skeletal and bone disorders.
5. Patients seeking medication for vitamin D deficiency. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the Vitamin D levels of young adults seeking orthodontic treatment.
2. To classify patients according to their Vitamin D status.
3. To assess, evaluate and compare the concentration of NTx and P1NP biomarkers in gingival crevicular fluid of Vitamin D deficient, Vitamin D insufficient and Vitamin D sufficient patients before and after 21 days of force application |
The concentration of Vitamin D will be assessed in serum at the beginning (T0). The concentration of P1NP and NTx biomarker will be assessed in gingival crevicular fluid at the beginning (T0) and 21 days after force application (T1). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of the baseline concentration of P1NP and NTx biomarkers in gingival crevicular fluid of Vit D Deficient, Vit D Insufficient and Vit D Sufficient subjects.
2.Assessment of the correlation between P1NP and NTx biomarkers before and after orthodontic force application among Vit D Deficient, Vit D Insufficient and Vit D Sufficient groups.
3.Determination of prevalence of Vit D Deficiency among the sample population.
4.Determination of the demographical differences in Vit D status among the sample population. |
The concentration of Vitamin D will be assessed in serum at the beginning (T0). The concentration of P1NP and NTx biomarker will be assessed in gingival crevicular fluid at the beginning (T0) and 21 days after force application (T1). |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
24/04/2024 |
| 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="1"
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
|
45 patients fulfilling inclusion and exclusion criteria will be recruited for this study and Vitamin D level will be assessed in the serum before the start of maxillary canine retraction (T0). The patients will be classified into 3 groups- Vitamin D sufficient, insufficient, and deficient. Gingival crevicular fluid will be also collected from maxillary canines just before the start of maxillary canine retraction (T0). The retraction of the maxillary canine will be done using closed NiTi coil springs using 150 gms force and Gingival crevicular fluid will be collected again after 21 days of force application (T1). Gingival crevicular fluid samples will be analyzed for biomarkers NTx and P1NP levels responsible for bone remodeling using ELISA kits and compared among the three groups. |