| CTRI Number |
CTRI/2023/06/054378 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Vitamin D levels and jaw bone mineral density in females patients of implant therapy. |
|
Scientific Title of Study
|
Evaluation and Co-relation of vitamin D levels and jaw bone mineral density in premenopausal and postmenopausal female patients undergoing implant therapy. An In-vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Kanojia |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre (DMIHER) |
| Address |
Room no.202, Prosthodontics department, Sharad Pawar Dental College
Sharad Pawar Dental College (SPDC) ,Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7798270168 |
| Fax |
|
| Email |
drektak227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Borle |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre (DMIHER) |
| Address |
Room no.202, Prosthodontics department,Sharad Pawar Dental College .
Sawangi (Meghe).
Wardha
MAHARASHTRA
442001
India |
| Phone |
7879960525 |
| Fax |
|
| Email |
dranjaliborle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ekta Kanojia |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre (DMIHER) |
| Address |
Room number 202, Prosthodontics department,Sharad Pawar Dental College .
Sawangi (Meghe) .
Wardha
MAHARASHTRA
442001
India |
| Phone |
7798270168 |
| Fax |
|
| Email |
drektak227@gmail.com |
|
|
Source of Monetary or Material Support
|
| NA |
| Sharad Pawar dental college and Hospital (DMIHER) |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar dental college (DMIHER) |
| Address |
Sharad Pawar dental college (SPDC)(DMIHER), Sawangi (Meghe), Wardha, Maharashtra |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ekta kanojia |
Sharad Pawar Dental College |
Room Number 202 Department of Prosthodontics and crown and bridges Sawangi(Meghe) Maharashtra.
Wardha
MAHARASHTRA |
7798270168
drektak227@gmail.com |
| Ekta kanojia |
Sharad Pawar dental college |
Room Number 202, Department of Prosthodontics
Wardha
MAHARASHTRA |
7798270168
drektak227@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences(deemed to be University) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E838||Other disorders of mineral metabolism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POST-MENOPAUSAL PATIENTS |
Total 50 females included in study of which 25 premenopausal and 25 postmenopausal females patients. This Females will be tested to evaluate their Vitamin D levels. Electrochemiluminescence is being used to determine Vitamin D level in the blood.
BMD measurement of jaw is measured with cone beam computed tomography. And is recorded in Hounsfield units (HU) using Planmeca romexis viewer software.
Duration of intervention will be 18 months. |
| Comparator Agent |
PRE-MENOPAUSAL PATIENTS |
Total 50 females included in study of which 25 premenopausal and 25 postmenopausal females patients. This Females will be tested to evaluate their Vitamin D levels. Electrochemiluminescence is being used to determine Vitamin D level in the blood. BMD measurement of jaw is measured with cone beam computed tomography. And is recorded in Hounsfield units (HU) using Planmeca romexis viewer software.
Duration of the study will be of 18 months. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All premenopausal and Postmenopausal females [18 years to 70 years] either edentulous or partially edentulous and willing to participate in the study.
No history of oophorectomy or hysterectomy
For the test group subjects with history of vitamin D deficiency were chosen after confirmation with their medical records and cross-checking values of serum Vitamin D level (ng/ml).
Patient having unfavorable condition location and number of abutment teeth.
The patient should not have any medical conditions (besides osteoporosis) that would make implant treatment more complicated.
They should have no local disease or condition that could interfere with implant treatment such as periodontal disease endodontic problems caries occlusal problems tooth fracture tooth wear and bony lesions .
|
|
| ExclusionCriteria |
| Details |
Hyperparathyroidism, renal dystrophy, oophorectomy, and skeletal bone disorders significantly affect bone metabolism.
As well as the usage of bone-related medications such as corticosteroids, estrogens preparations, bisphosphonates, and vitamin D supplements.
Uncontrolled diabetes, Uncontrolled hypothyroidism, habit of Smoking, Alcoholics
Pregnancy
Psychological instability
Cancer radiation and chemotherapy
History of radiation therapy to the jaws
Habit of bruxism
Bad oral hygiene which continues despite of motivating treatment
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be the significant co-relation between Vitamin d and jaw bone mineral density in menopausal condition |
Assessment will be done at the end of the study. Total duration of study is 18 months . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the reduction in jaw Bone mineral density related to vitamin D deficiency in postmenopausal female patients undergoing implant therapy |
Assessment at the end of the study .Total duration of the study will be at 12 months & 18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/07/2023 |
| 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="8"
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
|
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Brief Summary
|
This Study aims to
Evaluate and co-relate Vitamin D levels and Jaw Bone mineral density in pre and
postmenopausal females undergoing implant therapy. Vitamin D is a vitamin as well as a hormone that
our bodies produce. It is a fat-soluble vitamin that has long been known to aid
in the absorption and retention of calcium and phosphorus, both of which are
essential for bone formation. The correlation of vitamin D level and menopausal
condition on jaw bone in relation to its bone mineral density for dental
implant therapy have not been well documented, therefore this study is planned
to be carried out. |