- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433374
COMPARISON OF THE EFFICIENCY OF MANUAL SINGLE HEADED AND TRIPLE HEADED TOOTHBRUSHES IN REMOVING DENTAL PLAQUE AND USER EXPERIENCE
COMPARISON OF THE EFFICIENCY OF MANUAL AND ELECTRIC TOOTHBRUSHES IN REMOVING DENTAL PLAQUE AND USER EXPERIENCE
Background: Poor oral hygiene can be the result of negligence or because people cannot take care of their own oral hygiene due to limited dexterity. Dental plaque results in dental decay and periodontal disease over time. The importance of good oral hygiene can not be underestimated, not only for maintaining good oral health but also for maintaining general health. The most widespread means of controlling plaque at home is the toothbrush. Toothbrushes are designed in a way so as to remove plaque more efficiently.
Objective: To compare the efficiency of different toothbrushes in removing dental plaque Methodology: This Randomized control study will be carried out at Different schools in Karachi, Pakistan. The duration of this study will be 6 months. In this study, the participants will be recruited using a simple random sampling method. A minimum sample size of 20 was chosen. The participants in this study were invited and included based on the following criteria: Age group 15-50 years. Both males and females. Individuals with no active dental or systemic diseases. Consenting participants or guardians providing consent for minors. The participants were excluded based on non-consenting individuals or guardians. Those with active oral infections or systemic conditions affecting oral health. Participants with a recent professional dental cleaning (within 3 months). Use of orthodontic appliances or prosthetics that may interfere with toothbrushing performance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karachi, Pakistan, 77440
- Bahira University Dental College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Accept healthy individuals
- Age group 21-25 years.
- Both males and females.
- Individuals with no active dental or systemic diseases.
- Consenting participants or guardians providing consent for minors
Exclusion Criteria:
1. Non-consenting individuals or guardians.
2. Those with active oral infections or systemic conditions affecting oral health.
3. Participants with a recent professional dental cleaning (within 3 months).
4. Use of orthodontic appliances or prosthetics that may interfere with toothbrushing performance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: single headed brush
|
manual sigle headed toothbrush
|
|
Experimental: triple headed brush
|
triple -headed manual toothbrush for adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
decrease in dental plaque and gingival scores
Time Frame: 1 month
|
Scores reduction from pre to post.
Mean plaque scores of between 0.1 - 0.5 will be considered normal, and the more the scores indicatea worst case
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
decrease in gingival scores
Time Frame: 1 month
|
Scores reduction from pre to post, the more the scores, the worst is the case, 0.1-0.5 mean gingival scores will be considered normal
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dow UHS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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