| CTRI Number |
CTRI/2024/07/070073 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out presence of harmful bacteria in people with different stages of gum disease and their resistance to antibiotics |
|
Scientific Title of Study
|
Antibiogram and prevalence of Gram negative bacteria in subjects with different stages of periodontitis : a clinico-microbiological 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 |
Anu Mathew |
| Designation |
Postgraduate resident |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11,
Department of Periodontics and Oral Implantology,
Mar Baselios Dental College, Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9074842615 |
| Fax |
|
| Email |
anumathewkunnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayan Jacob Mathew |
| Designation |
Professor and Vice Principal |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11,
Department of Periodontics and Oral Implantology,
Mar Baselios Dental College, Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9447160349 |
| Fax |
|
| Email |
jayanjm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayan Jacob Mathew |
| Designation |
Professor and Vice Principal |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11,
Department of Periodontics and Oral Implantology,
Mar Baselios Dental College, Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9447160349 |
| Fax |
|
| Email |
jayanjm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mar Baselios Dental College,Thangalam,Kothamangalam,Ernakulam,Kerala,India,Pin : 686691 |
|
|
Primary Sponsor
|
| Name |
Anu Mathew |
| Address |
Mar Baselios Dental College, Thangalam, Kothamangalam, Ernakulam, Kerala |
| 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 |
| Anu Mathew |
Mar Baselios Dental College |
Room no 11,
Department of Periodontics and Oral Implantology,
Mar Baselios Dental College, Thangalam, Kothamangalam
Ernakulam
KERALA |
9074842615
anumathewkunnath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL REVIEW COMMITTEE,MAR BASELIOS DENTAL COLLEGE,KOTHAMANGALAM,KERALA - 686691 |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with periodontitis as per 2017 AAP classification
2. Systemically healthy individuals
3. Patient with age group from 30-60yrs
4. Patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any periodontal therapy in past 6 months.
2. Patients undergoing orthodontic treatment
3. Patients with systemic diseases (e.g. diabetes, hypertension)
4. Patients who are edentulous.
5. Use of topical or systemic antimicrobials in the last 6 months
6. Use of anti-inflammatory drugs in the last 3 months
7. Smoking or use of smokeless tobacco
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of Gram -negative bacteria in subgingival samples of patients with different stages of periodontal disease
2. Correlate prevalence of different Gram-negative bacteria with stages of periodontitis in the above patients
3. Determine antimicrobial susceptibility of Gram -negative bacteria from above samples
|
At initial visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This will be a cross sectional, observational study to estimate the prevalence and
determine the antimicrobial susceptibility of Gram- negative bacteria from
subgingival clinical isolates of patients with different stages of
periodontitis. The study will be conducted among the subjects
selected from the outpatient Department of Periodontics and Implantology, Mar
Baselios Dental College, Kothamangalam. A total of 80 patients will be recruited (20 per group). The
clinical parameters namely Plaque Index (PI), Gingival Index (GI), Probing
Pocket depth (PPD) and Clinical Attachment Levels (CAL) will be assessed and
the patients will be divided into different stages of periodontitis according
to 2017 AAP classification. Samples will be
collected from the gingival sulcus of selected teeth (after removal of
supragingival calculus) using curettes and will be transferred immediately
into BHI broth. The broth will immediately be sent to microbiology lab for
further evaluation.
|