| CTRI Number |
CTRI/2024/09/074422 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Diagnostic
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of implant longevity among two groups in low vitamin D3 Patients |
|
Scientific Title of Study
|
Comparative evaluation of implant stability in low vitamin D3 patients with and without vitamin D3 supplementation A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh Shivajirao Patil |
| Designation |
Post graduate student |
| Affiliation |
DR.HSRSM DENTAL COLLEGE AND HOSPITAL,HINGOLI |
| Address |
DR.HSRSM Dental college and hospital Basamba phata Akola road Hingoli Maharashtra
Hingoli
MAHARASHTRA
431513
India |
| Phone |
8103075555 |
| Fax |
|
| Email |
patilmukesh0777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHAY NARAYANE |
| Designation |
READER |
| Affiliation |
DR.HSRSM DENTAL COLLEGE AND HOSPITAL,HINGOLI |
| Address |
DEPARTEMENT OF PROSTHODONTICS AND CROWN AND BRIDGE DR.HSRSM DENTAL COLLEGE AND HOSPITAL BASAMBA PHATA AKOLA ROAD HINGOLI MAHARASHTRA
DR.HSRSM DENTAL COLLEGE AND HOSPITAL BASAMBA PHATA AKOLA ROAD HINGOLI MAHARASHTRA
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9960973901 |
| Fax |
|
| Email |
abhay.narayane16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Abhay Narayane |
| Designation |
Reader |
| Affiliation |
DR.HSRSM DENTAL COLLEGE AND HOSPITAL,HINGOLI |
| Address |
Department of Prosthodontics and crown and bridge Dr HSRSM Dental college and hospital Basamba phata Akola road Hingoli Maharashtra
Hingoli
MAHARASHTRA
431513
India |
| Phone |
9960973901 |
| Fax |
|
| Email |
abhay.narayane16@gmail.com |
|
|
Source of Monetary or Material Support
|
| private hospital Dr HSRSM Dental college and hospital Basamba phata Akola road Hingoli 431513 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh shivaji patil |
| Address |
DR HSRSM DENTAL COLLEGE AND HOSPITAL BASAMBA PHATA AKOLA ROAD HINGOLI MAHARASHTRA |
| 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 Mukesh Shivaji Patil |
HSRSM dental college and hospital hingoli |
Department of Prosthodontic and crown and bridge akola road basamba phata hingoli
Hingoli
MAHARASHTRA |
8103075555
patilmukesh0777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.HSRSM Dental college and hospital basamba phata akola road Hingoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VITAMIN D3[WELL B D3] Cholecalciferol |
VITAMIN D3[WELL B D3] Cholecalciferol chewable tablets 60,000 I.U.given by oral route once in a week mfg by BELIEVEWELLNESS INTERNATIONAL LIMITED |
| Comparator Agent |
with vitamin D3 supplementation in low vitamin D3 level patients |
with vitamin D3 supplementation in low vitamin D3 level patients |
| Comparator Agent |
without vitamin D3 supplementation in low vitamin D3 level patients |
without vitamin D3 supplementation in low vitamin D3 level patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with posterior edentulous spaces having D2
and D3 bone quality.
2. Patients within the age group of 20–45 years of either gender.
3. Individuals with good systemic health with no known
contraindication for surgery.
4. Presence of adequate bone volume to accommodate an implant of
appropriate size all around the implant .
5.All patients with vitamin D level below 30ng/ml. |
|
| ExclusionCriteria |
| Details |
1. If there was any anterior edentulous spaces present.
2. If the edentulous sites had any signs of acute infection.
3. If the patient had a medical history that would compromise the
treatment outcome.
4. Patients with parafunctional habits and temporal mandibular joint
disorders
5. Pregnant or lactating women.
6. Chronic smokers and alcoholics .
7. Patients allergic to any medicines which are likely to be used
during the treatment period. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate the relationship between implant stability
and vitamin D3 level with and without vitamin D3 supplementation
by using resonance frequency analyzer (osstell-ISQ) . |
12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate implant stability quotient (ISQ) - at the time of implant
placement.
2.To evaluate implant stability quotient after vitamin D3
supplementation .
3.To compare and evaluate relation between implant stability and
vitamin D3 level at the time of implant placement .
4.To compare and evaluate implant stability with vitamin D3 levels
after vitamin D3 supplementation. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
05/10/2024 |
| 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="1"
Months="0"
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 study is randomized controlled trial to evaluate the implant stability in low vitamin d patients with and without vitamin d supplementation . |