Chronic Gingivitis, Plaque InducedNCT03287011
Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures
A study testing Shoplaq toothpaste and Colgate toothpaste in people with Chronic Gingivitis, Plaque Induced, run by Segi University at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Gingivitis, Plaque Induced
- What is being tested?
- Shoplaq toothpaste and Colgate toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 11 Sep 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Avita Rath
Petaling Jaya, Selangor, 47810
Avita Rath, MDS, 60109677452, avitashanti@segi.edu.my
About this study
Official title: Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Chronic Gingivitis, Plaque Induced
- Being tested
- Shoplaq toothpaste, Colgate toothpaste
- Keywords
- dental plaque, tooth pastes, oral hygiene
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoplaq toothpasteOther
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.
Colgate toothpasteOther
fluoridated
| Study group | Role | What they receive |
|---|---|---|
| Control tooth paste | Active comparator | controlled fluoridated toothpaste will be provided for brushing to both the groups initially Receives: Other: Colgate toothpaste |
| Shoplaque tooth paste | Experimental | Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit Receives: Other: Shoplaq toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque removal efficacy of a disclosing toothpaste
Silness and Loe plaque index
Measured: from Baseline to 1 year
Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
Loe and Silness gingival index
Measured: from Baseline to 1 year
Secondary outcomes (3)
digital image analysis
MATLAB software for digital image analysis
Measured: from Baseline to 1 year
adverse effects
To record any side effects or adverse effects of the toothpaste seen by the patient or
clinician. soft tissue changes, taste alteration
Measured: baseline to 1 year
patient perceived outcomes
self-administered questionnaire.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start11 Sep 2017
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Gingivitis, Plaque InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional preventive trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Segi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avita Rath, Segi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287011
- Sponsor's protocol ID
- SUKD
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: article with study description and result
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03287011
- Acronym / sponsor ID
- SUKD
- Conditions
- Chronic Gingivitis, Plaque Induced
- Keywords
- dental plaque, tooth pastes, oral hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Segi UniversityUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- interventional preventive trial
| Arm | Type | Receives |
|---|---|---|
| Control tooth paste | Active comparator | Other: Colgate toothpastecontrolled fluoridated toothpaste will be provided for brushing to both the groups initially |
| Shoplaque tooth paste | Experimental | Other: Shoplaq toothpasteFluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoplaq toothpasteACTIVE 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 | Shoplaque tooth paste |
| Colgate toothpastefluoridated | Other | Control tooth paste |
Primary outcome
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
3 secondary outcomes
digital image analysis
Time frame: from Baseline to 1 year
adverse effects
Time frame: baseline to 1 year
patient perceived outcomes
Time frame: baseline to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Yes. article with study description and result
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoplaq toothpaste and Colgate toothpaste in people with Chronic Gingivitis, Plaque Induced, run by Segi University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque removal efficacy of a disclosing toothpaste (time frame: from Baseline to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.