| CTRI Number |
CTRI/2025/08/093026 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Checking the bacterial content and count from the calculus collected below the teeth gum level in the oral cavity using 16s rRNA gene sequencing technique and their standard antibiotic resistance in gum disease patients |
|
Scientific Title of Study
|
Estimation of subgingival microbiota using 16s rRNA gene sequencing and antibiotic susceptibility in Periodontitis patients - A Pilot 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 Gadi Kameswari Lakshmi Manasa |
| Designation |
Post Graduation Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of Periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9542123549 |
| Fax |
|
| Email |
manasa.periodontics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Trinath Kishore D |
| Designation |
Professor |
| Affiliation |
GITAM Dental college and hospital |
| Address |
GITAM Dental College and Hospital
Department of Periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9949109930 |
| Fax |
|
| Email |
dentalcys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Trinath Kishore D |
| Designation |
Professor |
| Affiliation |
GITAM Dental college and hospital |
| Address |
GITAM Dental College and Hospital
Department of Periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9949109930 |
| Fax |
|
| Email |
dentalcys@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital
Department of Periodontics
Room no 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
Pin 530045 |
|
|
Primary Sponsor
|
| Name |
Dr Gadi Kameswari Lakshmi Manasa |
| Address |
Door no 45 58 14
Narasimhanagar
Near port stadium
Visakhapatnam
Andhra Pradesh
Pin 530024 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Gadi Kameswari Lakshmi Manasa |
GITAM Dental College and Hospital |
Department of Periodontics
Room number 6
Gandhinagar Campus
Pin 530045
Rushikonda
Visakhapatnam
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH |
9542123549
manasa.periodontics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collection of subgingival calculus samples |
The subgingival calculus samples were collected using sterile periodontal curettes placed in the periodontal pocket
The calculus samples will be sent for microbial culturing and 16s rRNA gene sequencing for isolation and identification and for antibiotic susceptibility testing |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female subjects with periodontitis
Presence of subgingival bands of calculus |
|
| ExclusionCriteria |
| Details |
Absence of periodontal pockets |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the microbial or periodontal pathogens present and their antibiotic susceptibility using standard antibiotics in the sample |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
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 4 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="0"
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
|
The title of the study is Estimation of subgingival microbiota using 16s rRNA gene sequencing and antibiotic susceptibility in Periodontitis patients A pilot study. A total of 9 patients with Periodontitis and having systemic conditions such as diabetes, habits such as smoking, and other conditions will be selected. The subgingival calculus samples will be collected from these patients using sterile curettes. These samples will be transferred to eppendorf tubes containing DMEM storage and transport medium for the transport of samples to the lab. These samples will undergo 16s rRNA gene sequencing for identification of subgingival microbial colonies along with pure culturing of highly prevalent colonies for antibiotic susceptibility using standard antibiotics and herbal extracts. |