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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 : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Avita Rath, Segi University

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.


Condition or disease Intervention/treatment Phase
Chronic Gingivitis, Plaque Induced Other: Shoplaq toothpaste Other: Colgate toothpaste Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Control tooth paste
controlled fluoridated toothpaste will be provided for brushing to both the groups initially
Other: Colgate toothpaste
fluoridated

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.





Primary Outcome Measures :
  1. Plaque removal efficacy of a disclosing toothpaste [ Time Frame: from Baseline to 1 year ]
    Silness and Loe plaque index

  2. 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


Secondary Outcome Measures :
  1. digital image analysis [ Time Frame: from Baseline to 1 year ]
    MATLAB software for digital image analysis

  2. 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


  3. patient perceived outcomes [ Time Frame: baseline to 1 year ]
    self-administered questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Malaysia
Avita Rath Recruiting
Petaling Jaya, Selangor, Malaysia, 47810
Contact: Avita Rath, MDS    60109677452    avitashanti@segi.edu.my   
Sponsors and Collaborators
Segi University

Responsible Party: Avita Rath, Dr, Segi University
ClinicalTrials.gov Identifier: NCT03287011     History of Changes
Other Study ID Numbers: SUKD
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: article with study description and result
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: July 2018
Access Criteria: through journal publication

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Avita Rath, Segi University:
dental plaque
tooth pastes
oral hygiene

Additional relevant MeSH terms:
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases