| CTRI Number |
CTRI/2025/07/092061 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare how much bacteria can leak into two different types of connections between dental implants and their abutments |
|
Scientific Title of Study
|
To comparatively evaluate the presence of microbial leakage at two types of implant abutment connections and adjacent sites of implant |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagnik Sardar |
| Designation |
PG Resident |
| Affiliation |
Surendera Dental College and Research Centre |
| Address |
Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7000466317 |
| Fax |
|
| Email |
sngsr2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJNI AGGARWAL |
| Designation |
PG Resident |
| Affiliation |
Surendera Dental College and Research Centre |
| Address |
Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7000466317 |
| Fax |
|
| Email |
rajniperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sagnik Sardar |
| Designation |
PG Resident |
| Affiliation |
Surendera Dental College and Research Centre |
| Address |
Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7000466317 |
| Fax |
|
| Email |
sngsr2024@gmail.com |
|
|
Source of Monetary or Material Support
|
| SURENDERA DENTAL COLLEGE AND RESEARCH CENTRE, Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar, Rajasthan 335001 |
|
|
Primary Sponsor
|
| Name |
SURENDERA DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar, Rajasthan, 335001 |
| Type of Sponsor |
Other [Private Dental college ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sagnik Sardar |
SURENDERA DENTAL COLLEGE AND RESEARCH CENTRE His Highness Gardens Sri Ganganagar Rajasthan 335001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagnik Sardar |
SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
Department of Periodontology and Oral Implantology, room number 4, His Highness Gardens, Sri Ganganagar, Rajasthan, 335001
Ganganagar
RAJASTHAN |
7000466317
sngsr2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Partially edentulous patients who are cooperative and motivated for dental implant treatment
Patients with adequate bone volume
Good generalized periodontal health
Patient is willing to follow the study protocol |
|
| ExclusionCriteria |
| Details |
Patients with any systemic diseases.
Patients having adverse habits tobacco use or smoking, alcohol etc.
Pregnant and lactating patients
Patients having allergy to the materials to be used during operation.
Patients having severe bruxism or clenching.
Patient on Immunosuppressed or immunocompromised drugs. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THERE WILL BE BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION AND THAT MIGHT LEAD TO FAILURE OF IMPLANT CAUSING PERI IMPLANTITIS |
9 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IF THERE WILL BE NO BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION THAT MIGHT LEAD TO NON FAILURE OF IMPLANTS
|
9 MONTHS |
| IF THERE IS NO BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION THEN THERE WILL BE NO FAILURE OF IMPLANTS |
9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/09/2025 |
| 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="1"
Months="6"
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
|
Dental implants offer a reliable solution for tooth replacement; however, microbial contamination at the implant-abutment interface (IAI) poses a significant risk to their long-term success. A microgap between the implant and abutment in two-part systems can allow the infiltration of fluids and bacteria, including enteric species like Escherichia coli, Klebsiella, and Enterobacter. These bacteria, typically found in the gastrointestinal tract, can colonize peri-implant sites due to poor hygiene or systemic conditions. Their strong biofilm-forming ability and virulence can trigger inflammation, leading to peri-implantitis and bone loss. Recent studies have investigated the characteristics of E. coli in oral infections, examining their virulence, antibiotic resistance, and phylogroups. Additionally, the design and precision of the implant-abutment connection greatly influence microbial leakage, yet comparative data remains limited. Antibiotic therapy, while beneficial, must be used judiciously due to resistance concerns. Maintaining strict oral hygiene remains essential in preventing bacterial colonization. Therefore, this study aims to evaluate bacterial leakage, specifically E. coli, at two different implant systems: once during abutment placement at 3 months and again at 6 months post-implant placement. Adjacent teeth will also be analyzed to better understand bacterial behavior and improve implant design and clinical protocols. |