| CTRI Number |
CTRI/2025/08/092142 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The power of vitamins D and K - enhancing bone health around dental implants |
|
Scientific Title of Study
|
To explore the synergistic influence of vitamin D and vitamin K and its supplementation on bone remodeling process in conventional dental implants – an interventional 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 BHOOMIKA T M |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
Bangalore Institute Of Dental Sciences, Department of Periodontology, Room no- 5, 3rd floor, 5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka,India - 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
7899846440 |
| Fax |
|
| Email |
bhoomika.talad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAVI J |
| Designation |
READER |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
Bangalore Institute of Dental Sciences, Department of Periodontology, room no - 5, 3rd floor, 5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka, India - 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
7899846440 |
| Fax |
|
| Email |
bhoomika.talad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHOOMIKA T M |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
Bangalore Institute of Dental Sciences, Department of Periodontology, room no - 5, 3 rd floor, 5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka,India - 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
7899846440 |
| Fax |
|
| Email |
bhoomika.talad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Institute of Dental Sciences, Department of Periodontology, room no - 5, 3rd floor, 5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka,India 560027 |
|
|
Primary Sponsor
|
| Name |
DR BHOOMIKA T M |
| Address |
Bangalore Institute of Dental Sciences, Department of Periodontology, room no - 5, 3rd floor, 5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka, India - 560027 |
| 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 BHOOMIKA T M |
Bangalore institute of dental sciences |
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA |
7899846440
bhoomika.talad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Bangalore Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M267||Dental alveolar anomalies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vitamin D and Vitamin K supplementation |
To optimize conditions for dental implant placement, each patients serum 25-hydroxy vitamin D levels will be measured beforehand. If levels are found to be low that is below 30 nanograms per milliliter, patients will be prescribed 60,000 IU of oral vitamin D capsules once a week. This supplementation will begin four weeks prior to implant placement and continue for four weeks afterward. Additionally, patients will take orally 100 mcg of vitamin K daily for the same eight-week total period that is four weeks before and four weeks after. Both vitamin D and vitamin K supplements should be taken with a meal rich in dietary fat to maximize absorption. |
| Comparator Agent |
Without supplementation (control group ) |
Each patient will be assessed for serum 25 hudroxy vitamin D levels. Patients with sufficient vitamin D levels that is more than 30 nanograms per milliliter will not be supplemented and continued with implant placement. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have edentulous areas in either the mandibular or maxillary region, or both, are suitable candidates for implant-based rehabilitation. |
|
| ExclusionCriteria |
| Details |
1. Any systemic or debilitating illness that impacts bone health (e.g., uncontrolled diabetes mellitus, osteoporosis)
2. Pregnant, lactating, and post-menopausal females.
3. History of radiation to head and neck.
4. Patients requiring ridge augmentation procedures.
5. Individuals who regularly use anti-inflammatory medication and steroids.
6. Regular intake of any medication that impacts on bone metabolism. (e.g., Anti-convulsants, opioids, anti-depressants)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Radiographic parameter through 1. Orthopantomography (OPG)
2.Cone – beam computed tomography (CBCT) – to assess
a. Type of the bone
b.Bone Mineral Density
c.Crestal bone loss
Biochemical analysis
1. Serum 25-hydroxy vitamin D levels
2. Serum vitamin K levels
3. Peri-implant sulcular fluid Osteocalcin level
|
The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index -Turesky – Gilmore – Glickman modification of Quigley Hein Plaque Index 1970
2. Gingival index - Loe & Silness 1963
3. Gingival phenotype – Based on transparency of the periodontal probe through gingival margin.
4. Width of keratinized mucosa
5. Full - mouth Periodontal Probing depth
Measurements will be recorded using manual UNC 15 periodontal probe
|
7th day as baseline after implant placement, 1 month & 3 months post implant placement |
1. Plaque Index - Turesky – Gilmore – Glickman modification of Quigley Hein Plaque Index 1970
2. Gingival index - Loe & Silness 1963
3. Gingival phenotype – Based on transparency of the periodontal probe through gingival margin.
4. Width of keratinized mucosa
5. Full - mouth Periodontal Probing depth
Measurements will be recorded using manual UNC 15 periodontal probe
|
7th day as baseline after implant placement, 1 month & 3 months post implant placement |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="9"
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
|
The methodology of this interventional clinical study involves enrolling 34 patients aged 20 to 50 years who require dental implant rehabilitation, at the Department of Periodontology, Bangalore Institute of Dental Sciences. Participants will be divided into two groups based on their baseline serum vitamin D levels. Group A will include individuals with sufficient vitamin D levels (that is more than 30 nanograms per milli liters, sample size of 17), while Group B will consist of those with low vitamin D levels (less than 30 nanograms per milli liters with sample size of 17), who will receive a combination of vitamin D3 (60,000 IU per week) and vitamin K2 supplementation (100 micrograms) for four weeks before and after implant placement. All participants will receive a single-stage, coated, tapered root-form dental implant following standard surgical protocols guided by CBCT evaluation. Clinical parameters such as Plaque Index, Gingival Index, gingival phenotype, width of keratinized mucosa, and full-mouth periodontal probing depth will be recorded. Radiographic assessments including cone-beam computed tomography (CBCT) and orthopantomograms (OPG) will be used to evaluate bone type, bone mineral density, will be assessed before implant placement and 3 month after implant placement and crestal bone loss will be assessed 1 month and 3 month post implant placement. Biochemical analyses will include serum levels of 25-hydroxy vitamin D and vitamin K using liquid chromatography, as well as osteocalcin levels in peri-implant sulcular fluid (PISF) at baseline (7th day), 1 month, and 3 months post-implant placement using ELISA. |