| CTRI Number |
CTRI/2025/07/090249 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative analysis of microbial growth between used charcoal and regular toothbrush with and without using disinfection in controlled Diabetic patients |
|
Scientific Title of Study
|
Evaluation of regular vs. charcoal toothbrush disinfection with 3 percent sodium hypochlorite spray in controlled type 2 diabetes mellitus patients -An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaustubh Ram |
| Designation |
3rd year MDS |
| Affiliation |
The oxford dental college |
| Address |
The Oxford Dental College, Bommanahalli, Bangalore, India
Room No. 3 Department of periodontology , The Oxford dental College, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha A N |
| Designation |
3rd year MDS |
| Affiliation |
The oxford dental college |
| Address |
The Oxford Dental college, Bangalore,
Room No. 3 Department of periodontology , The Oxford dental College, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9845203336 |
| Fax |
|
| Email |
sunaina1096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaustubh Ram |
| Designation |
3rd year MDS |
| Affiliation |
The oxford dental college |
| Address |
The Oxford Dental College, Bangalore,
Room No. 3 Department of periodontology , The Oxford dental College, Bangalore
KARNATAKA
560068
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College, Bommanahalli, Bangalore, India, 560068 |
|
|
Primary Sponsor
|
| Name |
M B Kaustubh Ram |
| Address |
No.943 SIRI next to weavers street school D kongadiyappa road ,Doddaballapur ,Bangalore rural, Karnataka, India , 561203 |
| Type of Sponsor |
Other [Self Sponcers] |
|
|
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 Kaustubh Ram |
The Oxford Dental college |
Room No. 3 Department of Periodontology , The oxford Dental college, Bommanahalli , Bangalore
Bangalore
KARNATAKA |
9916557585
kaustubhram007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. presence of at least 20 natural teeth
2. Individuals with Healthy periodontium based on 2017 World workshop on classification of Periodontal and peri implant diseases and condition
3.patients with controlled T2DM ( HbA1c less than 7% ) |
|
| ExclusionCriteria |
| Details |
1.Patients with Uncontrolled T2DM
2.Patients who have received Periodontal Therapy in the last 6 months
3.smokers
4.pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Colony forming units/ ml on Charcoal and Regular toothbrushes with and without Disinfection |
End of 1, 2, 3, 4, weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PD, plaque index , Gingival Index , HbA1C |
at End of 1,2,3,4 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
18/07/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Toothbrushing is essential for oral hygiene and preventing dental issues like caries and periodntal diseases . How ever used toothbrushes can harbor microorganism , increasing the risk of secondary infections susceptible individuals. studies have linked bacterial contamination - perticularly S.mutrants and S.aureus to opportunistic infection. Charcoal toothbrushes are often marketed for its antimicrobial benefits , but scientific evidence supporting their superiority over regular toothbrush is limited . effective toothbrush sensitization reduces bacterial load lowering disease transmission and secondary infection risk. So the aim of the study is to compare microbial load on charcoal and regular toothbrushes with and without disinfection in controlled T2DM patients after a week of use. |