- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03287011
Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures
Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.
Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases such as demineralization, dental caries, gingivitis, and periodontitis.
Tooth brushing and flossing have been the cornerstone of oral hygiene and health. However, the high incidence and prevalence of gum problems in both the developed and developing world show these mechanical routines are not enough. Furthermore, many patients find it difficult to comply with this daily regime of brushing and flossing. Consistent with problems associated with maintaining oral health, periodontal disease is one of the most common chronic infections in adults. According to Philstrom, et al. up to 90% of the world's population has or will suffer from periodontal disease.Thus, the maintenance of an adequate level of plaque control by the individual through his or her daily oral hygiene is vital to prevent and control periodontal disease. Studies demonstrate that poor oral hygiene is widespread with about 60% of plaque found on the surfaces of the teeth after brushing. This may be due to the lack of manipulative skills, lack of motivation and compliance.Hence, increasing education and improving brushing technique by improving oral hygiene products is one way to enhance plaque removal in everyday brushing. The ability to see plaque while brushing will enhance patient's awareness and encourage them to be more thorough when performing oral hygiene.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Petaling Jaya, Selangor, Malaysia, 47810
- Recruiting
- Avita Rath
-
Contact:
- Avita Rath, MDS
- Phone Number: 60109677452
- Email: avitashanti@segi.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students of SEGi must be aged 18 to 25 years with chronic generalized gingivitis 2)
- With no known systemic illness.
- Minimum of 12 anterior teeth present (canine to canine) in both upper and lower arches
Exclusion Criteria:
- Participants who are pregnant or nursing.
- A dental student or faculty or dental staff member.
- Who have been on antibiotics within two weeks prior to examination.
- Having dry mouth syndrome or significant food allergies.
- Have undergone any dental procedures or oral prophylaxis within 30 days prior to testing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control tooth paste
controlled fluoridated toothpaste will be provided for brushing to both the groups initially
|
fluoridated
|
EXPERIMENTAL: Shoplaque tooth paste
Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit
|
ACTIVE INGREDIENT Sodium Monofluorophosphate 1000 PPM INGREDIENTS Precipitated Calcium Carbonate, Sorbitol, Glycerin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Sodium Benzoate, DM Water, Colour CI-45410, Holy Basil Oil, Neem Oil, Citrus Oil, Thymol Oi, Clove Oil, Piper Betel Leaf Oil, Tea Tree Oil, Eucalyptus Oil, Peppermint Oil, Spearmint Oil. Dye containing tooth paste for disclosing plaque and efficient brushing for better oral health. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque removal efficacy of a disclosing toothpaste
Time Frame: from Baseline to 1 year
|
Silness and Loe plaque index
|
from Baseline to 1 year
|
Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
Time Frame: from Baseline to 1 year
|
Loe and Silness gingival index
|
from Baseline to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
digital image analysis
Time Frame: from Baseline to 1 year
|
MATLAB software for digital image analysis
|
from Baseline to 1 year
|
adverse effects
Time Frame: baseline to 1 year
|
To record any side effects or adverse effects of the toothpaste seen by the patient or clinician. soft tissue changes, taste alteration |
baseline to 1 year
|
patient perceived outcomes
Time Frame: baseline to 1 year
|
self-administered questionnaire.
|
baseline to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUKD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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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