| CTRI Number |
CTRI/2024/07/070133 [Registered on: 07/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparing swabbed versus spit saliva in the detection of gum disease bacteria and inflammation |
|
Scientific Title of Study
|
Comparative study of the efficacy of swabbed and spit saliva for detection of red complex bacteria and salivary inflammatory markers in periodontitis |
| 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 Majo Ambooken |
| Designation |
Professor and Head of the Department |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Periodontics and Oral Implantology
Room Number 11
Mar Baselios Dental College
Kothamangalam
Ernakulam
Ernakulam
KERALA
686691
India |
| Phone |
9447268750 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majo Ambooken |
| Designation |
Professor and Head of the Department |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Periodontics and Oral Implantology
Room Number 11
Mar Baselios Dental College
Kothamangalam
Ernakulam
Ernakulam
KERALA
686691
India |
| Phone |
9447268750 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Majo Ambooken |
| Designation |
Professor and Head of the Department |
| Affiliation |
Mar Baselios Dental College |
| Address |
Department of Periodontics and Oral Implantology
Room Number 11
Mar Baselios Dental College
Kothamangalam
Ernakulam
Ernakulam
KERALA
686691
India |
| Phone |
9447268750 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Oral Implantology
Room Number 11
Mar Baselios Dental College
Kothamangalam
Ernakulam
Kerala
India
686691 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Majo Ambooken |
Mar Baselios Dental College |
Department of Periodontics and Oral Implantology
Room Number 11
Kothamangalam
Ernakulam
Ernakulam
KERALA |
9447268750
drmajoa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Committee MBDC |
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 |
| Comparator Agent |
Red complex bacteria & inflammatory markers |
To compare the efficacy of swabbed and spit saliva samples at four degree celsius and room temperature for the detection of red complex bacteria (Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola) and salivary inflammatory markers (IL6, TNF-α, NF-κB) in individuals diagnosed with periodontitis for a period of 3 months using RT PCR. |
| Intervention |
Spit saliva and swabbed saliva |
To determine the efficacy of swabbed and spit saliva samples at four degree celsius and room temperature in individuals diagnosed with periodontitis for a period of 3 months using RT PCR. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 18 years and older.
2. Subjects diagnosed with periodontitis as per the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
3. Subjects who have not undergone any periodontal therapy in the past six months
|
|
| ExclusionCriteria |
| Details |
1. Participants with systemic diseases that could affect periodontal health (e.g., uncontrolled diabetes).
2. Participants currently undergoing periodontal treatment.
3. History of antibiotic use within the past three months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of red complex bacteria in swabbed and spit saliva at 4 degree Celsius and room temperature |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To detect whether the swabbed or spit saliva is better for the detection of red complex bacteria and also to identify the suitable temperature. |
3 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="0"
Months="3"
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
|
To compare the efficacy of swabbed and spit saliva samples at 4°C and room temperature for the detection of red complex bacteria (Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola) and salivary inflammatory markers (IL6, TNF-α, NF-κB) in individuals diagnosed with periodontitis. Swabbed saliva will be collected by keeping the swab in the lingual vestibule, below the tongue, for 20 s. Spit saliva will be collected by asking the participant to expectorate into a sterile container. Saliva samples will be processed for the detection of red complex bacteria (P. gingivalis, T. forsythia, and T. denticola) & salivary inflammatory markers (IL6, TNF-α, NF-κB) using Multiplex RT-PCR test kits.
|