| CTRI Number |
CTRI/2024/05/066722 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare different types of toothbrushes to see how well they clean your mouth, how quickly they wear out, and what people think about using them |
|
Scientific Title of Study
|
Comparison Of Conventional Soft bristled and Nano bristled toothbrushes on Oral Hygiene status, Toothbrush wear and Patient reported outcome measures – A Randomized Clinical Trial |
| 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 Thota Saranya |
| Designation |
Postgraduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7036356905 |
| Fax |
|
| Email |
saranyatrendy11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhulika Banerjee |
| Designation |
Senior Lecturer |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7339749490 |
| Fax |
|
| Email |
banerjeemadhulika12693@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur , Bhimavaram-534202, West Godavari District |
|
|
Primary Sponsor
|
| Name |
Dr Thota Saranya |
| Address |
Block 2, Room No 7, Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram |
| 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 |
| Dr Thota Saranya |
Vishnu Dental College |
Block 2 Room No 7 Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
7036356905
saranyatrendy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional soft bristled toothbrush |
Patients will be instructed to brush their teeth twice daily for 2 min using the toothbrush and Colgate total dentifrice given for the study purpose in modified bass technique and not to use any other interdental aids and undergo any oral hygiene procedures.Clinical evaluation of OHI-S index, Plaque Index and Gingival Index will be done at baseline, 1 month, 2 months and 3 months.Tooth brush wear will be assessed at 1 month and 3 months. |
| Intervention |
Nano charcoal bristled toothbrush |
Patients will be instructed to brush their teeth twice daily for 2 min using the toothbrush and Colgate total dentifrice given for the study purpose in modified bass technique and not to use any other interdental aids and undergo any oral hygiene procedures.Clinical evaluation of OHI-S index, Plaque Index and Gingival Index will be done at baseline, 1 month, 2 months and 3 months.Tooth brush wear will be assessed at 1 month and 3 months.Patient reported outcome measured at 3 months |
| Intervention |
Nano Silicone bristled toothbrush |
Patients will be instructed to brush their teeth twice daily for 2 min using the toothbrush and Colgate total dentifrice given for the study purpose in modified bass technique and not to use any other interdental aids and undergo any oral hygiene procedures.Clinical evaluation of OHI-S index, Plaque Index and Gingival Index will be done at baseline, 1 month, 2 months and 3 months.Tooth brush wear will be assessed at 1 month and 3 months.Patient reported outcome measured at 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Age range of 18-45years
2)Non- smokers
3)Controlled systemic conditions
4)Good oral health
5)Six teeth excluding third molar in each quadrant with no crowns, orthodontic appliances
6)No periodontal pocket ≥3 mm or attachment loss ≥2 mm
|
|
| ExclusionCriteria |
| Details |
1)Patients with uncontrolled systemic diseases
2)Pregnancy or lactating women
3)Chronic smokers
4)Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C)
5)Patients with any known allergies to new materials
6)Patients with mucogingival problems
7)Patients with fixed or removable prosthesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Oral Hygiene Index Simplified (OHI-S),Plaque Index and Gingival Index |
Assessment of Oral Hygiene Index-OHI-Simplified (OHI-S), Plaque Index and Gingival Index will be assessed at baseline, 1 month, 2 months and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess Toothbrush wear
2) Patient reported outcome measures |
1)Toothbrush wear will be assessed at 1 month and 3 months
2)Patient reported outcome measures will be assessed at 3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
26/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 present study compares Oral Hygiene status, Toothbrush wear and Patient reported outcome measures of conventional soft bristled and Nano bristled toothbrushes. Students and individuals following inclusion criteria will be selected for this study. Randomization will be done and individuals will be divided into three group. For One group, Conventional soft bristled toothbrushes will be given. For Second group, Nano silicone bristled toothbrushes will be given. For third group, Nano charcoal bristled toothbrushes will be given. Individuals will be instructed to brush their teeth twice daily for 2 min using the toothbrush and Colgate dentifrice given for the study purpose in modified bass technique and not to use any other interdental aids and undergo any oral hygiene procedures.Oral Hygiene Index-Simplified, Plaque Index, Gingival Index will be assessed at baseline, 1 month, 2 months and 3 months. Toothbrush wear will be assessed at 1 month and 3 months. Patient reported outcome measures will be assessed at 3 months.
|