| CTRI Number |
CTRI/2024/10/074941 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of serum Vitamin D level (level of Vitamin D in blood) and implant osseointegration (fusion of implant to surrounding bone) |
|
Scientific Title of Study
|
Association of serum Vitamin D level and implant osseointegration - a prospective 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 |
Minati Jagadev |
| Designation |
scholar |
| Affiliation |
Rajiv Gandhi University of Health Scinces |
| Address |
Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari dental college and hospital
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
8658811382 |
| Fax |
|
| Email |
minati1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit S |
| Designation |
professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental college and hospital
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
9845439046 |
| Fax |
|
| Email |
rohit.srikanthan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Minati Jagadev |
| Designation |
scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari dental college and hospital
No.14, Ramohalli Cross, Mysore Road, Kumbalgodu
Bangalore
KARNATAKA
560074
India |
| Phone |
8658811382 |
| Fax |
|
| Email |
minati1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| No.14, Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental College and Hospital, Ramohalli Cross, Mysore Road, Kumbalgodu, Bangalore - 560074 , Karnataka |
|
|
Primary Sponsor
|
| Name |
Minati Jagadev |
| Address |
Room no. 3, Department of Oral and Maxillofacial Surgery, No.14, Rajarajeswari Dental College and Hospital, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka - 560074 |
| 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 Minati Jagadev |
Rajarajeswari Dental College and Hospital |
No.14, Room no. 3, Department of Oral and Maxillofacial Surgery, Rajarajeswari Dental College and Hospital, Ramohalli Cross, Mysore Road, Kumbalgodu - 560074
Bangalore
KARNATAKA |
8658811382
minati1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College and Hospital Institutional IEC certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dental Implant placement |
Dental implant will be place in edentulous area of patients qualifying the inclusion criteria and the primary stability at the time of implant placement and secondary stability of the implant at 3rd and 6th month will be checked. the stability will be correlated to the Serum Vitamin D levels of the patient pre-op and post-op at 3rd and 6th month to analyse if Vitamin D serum levels affect implant osseointegration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. subjects within age group of 18 -50 years
2. partially edentulous sites
3. willing for implant prosthesis
4. belonging to ASA class I category |
|
| ExclusionCriteria |
| Details |
1. subjects who are chronic alcoholics or/and smokers;
2. pregnant or lactating women;
3. immunocompromised patients;
4. subjects under vitamin D, calcium or any other vitamin supplements;
5. subjects under bisphosphonates therapy;
6. subjects with poor oral hygiene;
7. subjects with bone disorders;
8. subjects with irradiation to implant placement area
9. subjects who fail to achieve primary implant stability |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| implant stability |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| implant stability |
6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
02/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The success of dental implant depends upon the osseointegration of the implant which increases implant stability. Vitamin D , a steroid hormone, in its active form regulates bone mineral homeostasis by calcium and phosphorous metabolism and osteoblastic and osteoclastic activities. Adequate vitamin D level is essential for maintaining bone density as well as for healing by repair and regeneration of bone around the implant. Therefore optimal vitamin D level can improve osseointegration of implant. Vitamin D deficiency is seen worldwide and serum Vitamin D level relation to implant osseointegration is not fully understood. Hence the hypothesis of the study is that optimal serum Vitamin D level is necessary and might enhance implant osseointegration and thereby increase implant stability.
The aim of the study is to evaluate the association of serum vitamin D level and implant osseointegration. The objectives being to evaluate periodic serum vitamin D leve, evaluate primary and secondary stability of the implant at 3rd and 6th months and to correlate the ISQ to the serum vitamin D level.
The study will be performed on 25 patients selected on the basis of inclusion and exclusion criteria with written consent of the patient. Inclusion criteria - partial edentulous site , age - 18-50 yr , ASA class I exclusion criteria - chronic smoker/ alcoholics , pregnant / lactating women , pt under bisphosphonates or any supplements including vitamin D and Calcium, immunocompromised patient, poor oral hygiene, patient with bone disorders or irradiation to implant site , patient not achieving primary stability
The procedure will involve routine blood investigation with serum vitamin D levels, CBCT pre- op and post- op 3rd and 6th month to compare bone regeneration around implant and insertion torque test and ISQ to measure the stability of the implant intra-op and post op at 3rd and 6th months. The CBCT and ISQ data will then be correlated to the the patient’s serum vitamin D levels intra-op and in the 3rd month and 6th month.
All the 25 patient’s data will be compared to evaluate if there exist any association between Vitamin D serum levels and implant osseointegration. The statistical analysis will be carried out using student paired T test, ANOVA, Simple linear regression and other relevant tests if found appropriate.
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