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Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures

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ClinicalTrials.gov Identifier: NCT03287011
Recruitment Status : Unknown
Verified September 2017 by Avita Rath, Segi University.
Recruitment status was:  Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Avita Rath, Segi University

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 19, 2017
Last Update Posted Date September 19, 2017
Actual Study Start Date  ICMJE September 11, 2017
Estimated Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures
Official Title  ICMJE Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.
Brief Summary

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.

Detailed Description Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases such as demineralization, dental caries, gingivitis, and periodontitis. 1 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 which can result in tooth mobility and tooth loss. 2 Tooth brushing and flossing have been the cornerstone of oral hygiene and health.2 However, the high incidence and prevalence of gum problems in both the developed and developing countries show these mechanical routines are not enough. 1 Studies demonstrate that poor oral hygiene is widespread with about 60% of plaque found on the surfaces of the teeth after brushing.3 Furthermore, many patients find it difficult to comply with this daily regimen of brushing and flossing. 2 This may be due to the lack of manipulative skills, lack of motivation and compliance. 2 According to an overview of the challenges in dental public health in Malaysia by Allan Kah, he stated that only 26% of 15-19-year-old and only 5% of 35-44-year-olds have been reported to have healthy periodontal tissues. 4 Studies such as the one done by Deliargyris, showed that periodontal disease was associated with the enhanced systemic inflammatory response with various mediators. Thus, it may contribute to systemic diseases. For example, periodontal disease has been linked to atherosclerosis via an increased level of serum C-reactive protein, a marker for inflammation and a high-risk factor for coronary artery disease.5 Hence, there is a need to increase education and improve brushing technique. This can be done by improving oral hygiene products by incorporating a plaque disclosing dye in the toothpaste.1 The ability to see plaque while brushing will enhance patient's awareness and encourage them to be more thorough when performing oral hygiene. 1 Previous studies done by the Department of Orthodontics, University of Illinois have shown that using a toothpaste with a plaque indicating dye such as PlaqueHD® to disclose plaque while brushing resulted in more than four times as much plaque elimination between visits (51.3% reduction, p = 0.015) than participants using only the placebo toothpaste (8.3% reduction, p=0.189). 1 However, one of the limitations of the product used in that study is the high cost of the toothpaste and the difficulty in obtaining the toothpaste in South East Asia.Hence, the present study aims to assess the efficacy of a plaque disclosing toothpaste that is easily available and affordable which was developed with the Health Promotion Board of Singapore, named Shoplaq® in reducing dental plaque.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Prevention
Condition  ICMJE Chronic Gingivitis, Plaque Induced
Intervention  ICMJE
  • 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.

  • Other: Colgate toothpaste
    fluoridated
Study Arms  ICMJE
  • Active Comparator: Control tooth paste
    controlled fluoridated toothpaste will be provided for brushing to both the groups initially
    Intervention: Other: Colgate toothpaste
  • Experimental: Shoplaque tooth paste
    Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit
    Intervention: Other: Shoplaq toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2018
Estimated Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03287011
Other Study ID Numbers  ICMJE SUKD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: article with study description and result
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: July 2018
Access Criteria: through journal publication
Responsible Party Avita Rath, Segi University
Study Sponsor  ICMJE Segi University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Segi University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP