| CTRI Number |
CTRI/2026/02/102790 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe the level of titanium ions released before and after the placement of dental implanys in saliva |
|
Scientific Title of Study
|
Assessing Titanium ion release in saliva after placement of dental implant: A Prospective cohort 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 Sangeeta Gupta |
| Designation |
MDS Student |
| Affiliation |
Panjab University |
| Address |
Department of Periodontics Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25,Panjab university
Chandigarh
CHANDIGARH
160025
India |
| Phone |
6283683050 |
| Fax |
|
| Email |
sangeetagupta.07sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head |
| Affiliation |
Panjab University |
| Address |
Department of Periodontics Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25,Panjab university
Chandigarh
CHANDIGARH
160025
India |
| Phone |
9888000444 |
| Fax |
|
| Email |
ajain.pu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurparkash Singh Chahal |
| Designation |
Assistant Professor |
| Affiliation |
Panjab University |
| Address |
Department of Periodontics Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital Sector 25,Panjab university
Chandigarh
CHANDIGARH
160025
India |
| Phone |
9872978629 |
| Fax |
|
| Email |
gpchahal29@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL,Dr Harvansh Singh Judge Institute of Dental Sciences & Hospital, Sector- 25, Chandigarh, 160014 |
|
|
Primary Sponsor
|
| Name |
Dr Sangeeta Gupta |
| Address |
Department of periodontology Dr Harvansh Singh Judge Institute of Dental Sciences & Hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gurparkash Singh Chahal |
Department of periodontology Dr Harvansh Singh Judge Institute of Dental Sciences & Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangeeta Gupta |
Dr Harvansh Singh Judge Institute of Dental Sciences & Hospital |
Room no 108, Dept of Periodontology, Sector- 25, chandigarh
Chandigarh
CHANDIGARH |
6283683050
sangeetagupta.07sg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Panjab University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous patients |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Male or female
Subject equal or above 18 years
Systemically healthy patients for implants
Presence of edentulous site in mouth that is indicated for implant surgery
Voluntarily signing of informed consent
Subject commitment to the study and follow up visits. |
|
| ExclusionCriteria |
| Details |
• No prior placement of dental implant.
• Pregnant/lactating women
• Smokers, tobacco chewers, alcohol or drug addicts
• Systemic diseases or conditions such as metabolic diseases, bone and hematological diseases, immunodeficiency, uncontrolled diabetes mellitus, kidney failure, tumor or radiation in head and neck area or any other disease contraindicating implant placement
• Patients unwilling to complete the treatment protocol.
• Patient with history of allergic tendencies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Titanium levels |
Before implant placement
1 week, 1 month, 3 months, 6 months after implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Modified Plaque Index,
•Modified Gingival Index,
•Bleeding on Probing,
•Probing depth and
•Clinical attachment loss (CAL)
|
Before implant placement
1 week, 1 month, 3 months and 6 months after implant placement |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/02/2026 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sangeetagupta.07sg@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 01-08-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients will be recruited based on inclusion and exclusion criteria and explained about the nature of the study, the outcome of it, following which a verbal and written consent will be obtained. A complete history and full mouth clinical examination will be performed followed by full mouth SRP by manual and ultrasonic scalers. Single stage Implant placement will be done. Saliva sample will be collected before implant placement then 7th day, 1 month, 3 months and 6 months after implant placement. |