| CTRI Number |
CTRI/2024/07/070815 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the influence of Vitamin D3 supplements on the success of dental implants in Indian population. |
|
Scientific Title of Study
|
To study the influence of Vitamin D3 supplements on the available bone quality and success of dental implants in mandibular posterior region in Indian population. -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. Udita Choudhry |
| Designation |
Post Graduate Student |
| Affiliation |
SGT UNIVERSITY |
| Address |
Room no.103, Department of prosthodontics, crown and bridge and
oral implantology, Faculty of Dental Sciences, SGT University,
Budhera, Gurugram Badli Road, Gurugram Haryana
122505
Gurgaon
HARYANA
122505
India |
| Phone |
8800291343 |
| Fax |
|
| Email |
chaudharyudita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
SGT UNIVERSITY |
| Address |
Room no.103, Department of prosthodontics, crown and bridge and
oral implantology, Faculty of Dental Sciences, SGT University,
Budhera, Gurugram Badli Road, Gurugram Haryana
122505
Gurgaon
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
bhupender.yadav@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
SGT UNIVERSITY |
| Address |
Room no.103, Department of prosthodontics, crown and bridge and
oral implantology, Faculty of Dental Sciences, SGT University,
Budhera, Gurugram Badli Road, Gurugram Haryana
122505
Gurgaon
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
bhupender.yadav@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, SGT University,
Budhera, Gurugram Badli Road, Gurugram Haryana
122505 |
|
|
Primary Sponsor
|
| Name |
Dr Udita Choudhry |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and
oral implantology, Faculty of Dental Sciences, SGT university,
Budhera, Gurugram Badli Road, Gurugram Haryana
Gurgaon
HARYANA
122505
India
|
| 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 Udita Choudhry |
SGT University |
Room no. 103, Department of prosthodontics, crown and bridge and
oral implantology, Faculty of Dental Sciences, SGT university,
Budhera, Gurugram Badli Road, Gurugram Haryana
Gurgaon
HARYANA
122505
India
Gurgaon
HARYANA |
8800291343
chaudharyudita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College, Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group
1.Patients with low Vitamin D3 below 10 ng per dl
|
Patients with low Vitamin D3 levels below 10 ng per dl
but not on any Vitamin D3 supplements |
| Intervention |
Vitamin D3 supplements |
Vitamin D3 supplements, Cholecalciferol 60,000 IU/ month prescribed for a period of 4 weeks to patients with Vitamin D values less than 10 ng/dl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having at least one edentulous site for implant placement in mandibular posterior region.
2. Patients having minimum available tentative interocclusal space of 6-7 mm at the restorative site.
3. Patients with good oral hygiene.
4. Patients in the age group of 18 to 60 years.
5. Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
Patients with extremely low vitamin D less than 10 ng per dl.
Insufficient inter arch space.
Insufficient width and height requiring complex surgical procedures such as grafting or ridge split.
Unfavourable implant axis orientation.
Patients with TMJ disorders.
Immunocompromised patients.
Blood dyscrasias.
Heavy smokers more than 10 cigarettes per day.
Alcohol abusers.
Occlusal anomalies.
Parafunctional habits.
Recent history of acute illness.
Organic heart disease with marked signs of cardiac insufficiency.
Recent myocardial infarction of less than 6 months duration.
Unstable angina.
Patients with advanced degrees of pulmonary, renal or endocrine insufficiency.
Uncontrolled diabetes with complications to vascular or other organs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Influence of Vitamin D3 supplements on available bone quality and success of dental implants in mandibular posterior region |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate and compare role of Vitamin D3 on crestal bone loss and implant stability at time of loading and 3 months post loading |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| Date of Study Completion (India) |
20/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Long-term stable dental implants are the primary goal in the field of oral implantology. In order to achieve long-term success, the primary requisite is the phenomenon of osseointegration which is defined as a direct connection established between the bone and the implant surface, without the interposition of fibrous tissue. A low level of vitamin D has been associated with increased risk of implant failure. Recognition of various systemic risk factors associated with dental implants has shown that failure rates can be reduced, and predictability of success can be increased with introduction of Vitamin D3 supplements. |