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Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures

Primary Purpose

Chronic Gingivitis, Plaque Induced

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Shoplaq toothpaste
Colgate toothpaste
Sponsored by
Segi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Gingivitis, Plaque Induced focused on measuring dental plaque, tooth pastes, oral hygiene

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Avita RathRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control tooth paste

Shoplaque tooth paste

Arm Description

controlled fluoridated toothpaste will be provided for brushing to both the groups initially

Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit

Outcomes

Primary Outcome Measures

Plaque removal efficacy of a disclosing toothpaste
Silness and Loe plaque index
Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
Loe and Silness gingival index

Secondary Outcome Measures

digital image analysis
MATLAB software for digital image analysis
adverse effects
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
self-administered questionnaire.

Full Information

First Posted
September 11, 2017
Last Updated
September 16, 2017
Sponsor
Segi University
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1. Study Identification

Unique Protocol Identification Number
NCT03287011
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Segi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gingivitis, Plaque Induced
Keywords
dental plaque, tooth pastes, oral hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
interventional preventive trial
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control tooth paste
Arm Type
Active Comparator
Arm Description
controlled fluoridated toothpaste will be provided for brushing to both the groups initially
Arm Title
Shoplaque tooth paste
Arm Type
Experimental
Arm Description
Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit
Intervention Type
Other
Intervention Name(s)
Shoplaq toothpaste
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Colgate toothpaste
Intervention Description
fluoridated
Primary Outcome Measure Information:
Title
Plaque removal efficacy of a disclosing toothpaste
Description
Silness and Loe plaque index
Time Frame
from Baseline to 1 year
Title
Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
Description
Loe and Silness gingival index
Time Frame
from Baseline to 1 year
Secondary Outcome Measure Information:
Title
digital image analysis
Description
MATLAB software for digital image analysis
Time Frame
from Baseline to 1 year
Title
adverse effects
Description
To record any side effects or adverse effects of the toothpaste seen by the patient or clinician. soft tissue changes, taste alteration
Time Frame
baseline to 1 year
Title
patient perceived outcomes
Description
self-administered questionnaire.
Time Frame
baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Avita Rath
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47810
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avita Rath, MDS
Phone
60109677452
Email
avitashanti@segi.edu.my

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
article with study description and result
IPD Sharing Time Frame
July 2018
IPD Sharing Access Criteria
through journal publication

Learn more about this trial

Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures

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