| CTRI Number |
CTRI/2025/12/099390 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of healing around dental implants when using vitamin D solution in socket and when placed normally |
|
Scientific Title of Study
|
Comparative Study of Peri-Implant Tissue Response With and Without Topical Vitamin D Treatment During Implant Placement: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-6533 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjal Sati |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental And Medical Research Institute Majri Grant Dehradun Uttarakhand |
| Address |
Room No 10, Department of Periodontology and Oral Implantology,
Uttaranchal Dental And Medical Research Institute Majri Grant
Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7251838447 |
| Fax |
|
| Email |
pranu.sati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aaron F Gomes |
| Designation |
PG Guide, Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology and Oral Implantology,
Uttaranchal Dental And Medical Research Institute Majri Grant
Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjal Sati |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 10, Department of Periodontology and Oral Implantology,
Uttaranchal Dental And Medical Research Institute Majri Grant
Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7251838447 |
| Fax |
|
| Email |
pranu.sati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttaranchal Dental and Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Pranjal Sati |
| Address |
Post graduate student, Room No 10, Department of Periodontology and Oral Implantology,
Uttaranchal Dental And Medical Research Institute Majri Grant
Dehradun Uttarakhand. India. 248140 |
| 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 Pranjal Sati |
Uttaranchal Dental and Medical Research Institute |
Room No 10, Department of Periodontology and Oral Implantology,
Dehradun
UTTARANCHAL |
7251838447
pranu.sati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttaranchal Dental and Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental implant fixture placement by conventional technique. |
Dental implants fixtures shall placed by conventional preperation of implant osteotomy and irrigation of osteotomy with normal saline and no vitamin D solution prior to fixture insertion |
| Intervention |
Using vitamin D irrigation prior to dental implant fixture placement |
Dental implants fixtures shall placed by conventional preperation of implant osteotomy and irrigation of osteotomy with vitamin D solution prior to fixture insertion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. systemically healthy Indian patient
2. each an age of at least 18 years
3. partially edentulous
4. sufficient bone height/width for implant placement
5. ready to come for 6-month recall |
|
| ExclusionCriteria |
| Details |
1. previously diagnosed with vitamin D deficiency with serum vitamin D level of lessthan 10 ng/ml
2. diagnosed with chronic kidney disease, osteoporosis, ulcerative colitis, Crohn disease, or celiac disease
3. long term use of medication like phenytoin, phenobarbital, and rifampin
4. active periodontal infection (no periodontal pocket depth greater than 3 mm at the time of implant placement).
5. unresolved extraction wounds or inadequate bone at the time of implant placement
6. lack of motivation and/or compliance
7. moderate/heavy smoking
8. uncontrolled diabetes mellitus
9. bruxism
10. a medical condition that contraindicates surgery
11. pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri implant radiographic crestal bone level at mesial and distal aspect of the implant |
3- months and 6- months after implant fixture insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified Plaque Index |
6- months after implant placement |
| Peri-implant Mucosal Index |
6- months after implant placement |
| modified Sulcus Bleeding index |
6- months after implant placement |
| Misch’s Clinical Implant Mobility Scale |
6- months after implant placement |
| Peri-implant Sulcus Probing Depth |
6- months after implant placement |
| Peri-implant Clinical Attachment Level |
6- months after implant placement |
| Presence/Absence of Peri-implant Suppuration |
6- months after implant placement |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
29/12/2025 |
| 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
|
Background: Vitamin D has a positive role in calcium absorption and bone metabolism. Vitamin D deficiency has been implicated in the cause for early dental implant failure. Topical vitamin D application has been shown to offer good effects in osseointegration of dental implants in animal studies. Aim: To compare over a follow up period of 6 months the clinical response and peri-implant crestal bone level changes around dental implants that are placed with and without filling the surgically prepared osteotomies with vitamin D solution prior to placement of the implant fixture. Materials and Methods: A sample size of 20 implant sites has been calculated. These edentulous sites will be randomly assigned to test group (n=10) wherein the implant fixture will be placed in a surgically prepared osteotomy that has been filled with vitamin D solution, and the remaining to a group (n=10) wherein no such topical application of vitamin D in the osteotomy will be done prior to insertion of fixture.. The peri-implant crestal bone levels on an intraoral radiograph will be measured at time point of immediately after fixture surgery and after 3- and 6-months after surgery. Standardization of radiograph angle and position will be obtained by using a customized pre-fabricated radiograph holding stent. The peri-implant scores of modified Plaque Index, Peri-Implant Mucosal Index, modified Sulcus Bleeding Index, Misch’s Implant Mobility Scale, Peri-Implant Probing Depth, Peri-Implant Mucosal Margin level, Peri-Implant Clinical Attachment level, and the presence or absence of peri-implant suppuration. The full mouth scores of Plaque Index, Gingival Index, and percentage of Sulcus Bleeding sites will also be recorded. Data Analysis. The changes in peri-implant crestal bone levels levels, peri-implant clinical scores and periodontal scores will be compared between the two groups at respective time-points. The data will be analyses statistically with standard analysis of variance at a level of significance of p less than or equal to 0.05. |