Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures
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|ClinicalTrials.gov Identifier: NCT03287011|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Gingivitis, Plaque Induced||Other: Shoplaq toothpaste Other: Colgate toothpaste||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||interventional preventive trial|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Masking Description:||Toothpaste tubes will be masked so the care provider would not know which tube he/she allocating to the participants as well the outcome assessor would be masked from both groups ( test and control) so data is assessed unbiased.|
|Official Title:||Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.|
|Actual Study Start Date :||September 11, 2017|
|Estimated Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||April 30, 2018|
Active Comparator: Control tooth paste
controlled fluoridated toothpaste will be provided for brushing to both the groups initially
Other: Colgate toothpaste
Experimental: Shoplaque tooth paste
Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit
Other: Shoplaq toothpaste
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.
- Plaque removal efficacy of a disclosing toothpaste [ Time Frame: from Baseline to 1 year ]Silness and Loe plaque index
- 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
- digital image analysis [ Time Frame: from Baseline to 1 year ]MATLAB software for digital image analysis
- 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
- patient perceived outcomes [ Time Frame: baseline to 1 year ]self-administered questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287011
|Petaling Jaya, Selangor, Malaysia, 47810|
|Contact: Avita Rath, MDS 60109677452 firstname.lastname@example.org|