Clinical trial NCT03287011: Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures
Official title: Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Gingivitis, Plaque Induced
Keywords: dental plaque
tooth pastes
oral hygiene
Lead sponsor: Segi University
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional preventive trial
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Plaque removal efficacy of a disclosing toothpaste
timeFrame: from Baseline to 1 year
measure: Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
timeFrame: from Baseline to 1 year
Secondary outcomes:
measure: digital image analysis
timeFrame: from Baseline to 1 year
measure: adverse effects
timeFrame: baseline to 1 year
measure: patient perceived outcomes
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Avita Rath
state: Selangor
Study officials:
References: