Calculus, DentalNCT04381403
Development of a New Toothpaste for the Removal of Dental Calculus.
A study testing Bio-descaling D-Tart toothpaste and Crest® toothpaste in people with Calculus, Dental and Periodontal Diseases, run by Faleh Tamimi at 1 site in Canada.
Trial summary
Periodontal disease is amongst the most prevalent oral diseases worldwide and in North America. According to the 2007/09 Canadian Health Measures Survey, 16% of Canadian adults and 24% of older adults, 60 to 79 years of age, were found to have moderate periodontal disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calculus, Dental, Periodontal Diseases, Periodontal Inflammation
- What is being tested?
- Bio-descaling D-Tart toothpaste and Crest® toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2017to 30 Apr 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and over, to ensure compliance with the study instructions
- Systemically healthy to exclude the possibility of calculus formation due to disease;
- Has at least 20 sound natural teeth including all lower anterior teeth, the main location of calculus build up;
- Having the history of previous calculus formation (at least 1.5 mm of calculus width) on the lingual surfaces of the mandibular anterior teeth after 3- 6 months of receiving a professional prophylaxis treatment, for better assessment of the toothpaste effectiveness;
- Agree to follow the study instruction: adherence to study arm, for the study timeline.
Who cannot join
- Pregnancy: pregnant women at high risk of developing gum inflammation that usually occurs during pregnancy, which could introduce bias to the study;
- any physical handicap, psychological or health conditions that might jeopardize the ability of the patient to brush his/ her teeth, these complications cause bias in the study;
- Antibiotics or anti-inflammatory drugs are taken within 1 month prior to the study, to avoid bias when assessing the gum health;
- Currently using Chlorhexidine oral products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in our assessment of calculus removal by our toothpaste;
- Sensitivity to tartar-control toothpaste;
- Patients currently receiving dental treatment that would result in the removal of plaque or calculus and compromise our ability to measure calculus removed by the toothpaste;
- unable to return for evaluations/study recalls, to avoid the significant loss in the number of participants; 9) Having the diagnosis of Periodontal Screening and Recording scale (PSR) of 4, these type of patients have advanced periodontitis with a high risk of tooth loss (periodontal pockets of 6 mm and more) and could bias the treatment outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Toothpaste for the Removal of Dental Calculus: a Double-blind, Randomized Controlled Trial.
Periodontal disease is amongst the most prevalent oral diseases worldwide and in North America. According to the 2007/09 Canadian Health Measures Survey, 16% of Canadian adults and 24% of older adults, 60 to 79 years of age, were found to have moderate periodontal disease. Moreover, 11% of Canadian adults were found to have calculus scores in the highest range. On the other hand, recent reports on the prevalence of periodontitis in the US showed that 47.2% of adults aged 30 years and older have some form of periodontal disease and 70.1% of adults 65 years and older have periodontal disease. The estimates also showed that the expenditure for periodontal treatments in the US is about approximately $ 14.3 billion.
Since dental calculus plays an important etiological role in initiation and progression of periodontal diseases. Investigation and investment on preventive technologies to prevent the periodontal disease are important for any health care system and its end-users. Furthermore, the removal and prevention of dental calculus using an effective toothpaste could reduce the need for professional periodontal interventions or the time of these treatments that in turn reduces their cost and other burdens on patients.
The aim of this study is to assess the efficacy of D-Tart toothpaste in removing dental calculus compared to Crest® (Complete Whitening plus Scope, tartar control, Procter \& Gamble, Cincinnati, OH), anti-tartar toothpaste with similar pH and texture to D- Tart toothpaste.
- Being tested
- Bio-descaling D-Tart toothpaste, Crest® toothpaste
- Keywords
- Oral Hygiene, Calculus, Dental plaque
- Medical subject headings
- Dental Calculus, Periodontal Diseases, Calculi, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-descaling D-Tart toothpasteOther
Patients received Bio-descaling D-Tart toothpaste, which is a new dentifrice (Visionaturolab Inc., QC) that contains a natural bio-descaler powder of cuttlefish bone
Crest® toothpasteOther
Patients received Crest toothpaste; Anti-tartar toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Bio-descaling D-Tart toothpaste | Experimental | Bio-descaling D -Tart is a bio-descaler toothpaste that is manufactured at Du-Var laboratories (1460 Graham Bell, Boucherville, Québec, Canada J4B 6H5) Receives: Other: Bio-descaling D-Tart toothpaste |
| Crest® | Active comparator | anti-tartar toothpaste, Complete Whitening plus Scope, tartar control produced by Procter \& Gamble, Cincinnati, OH), Receives: Other: Crest® toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calculus index
Calculus level in mm on teeth before and after brushing with toothpaste.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (3)
Modified Gingival Index
semi-quantitative assessment of gingival health around each tooth
Absence of inflammation; Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
Moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration
Measured: Baseline, 3 months, 9 months
Shaw and Murray Stain Index
Quantitative assessment of extrinsic stains on the labial and palatal/lingual surfaces of the upper and lower central and lateral incisors; The outline of the labial and lingual surfaces of all eight incisor teeth are enlarged to scale (magnification X 4) and each tooth face divided into 4-mm squares. All areas of extrinsic stain are drawn by the examiner on a grid system and then measured.
Measured: baseline, 3 months, 9 months
Quigley-Hain plaque index (QHI)
semi-quantitative assessment of plaque around each tooth;
Score 0: No plaque Score 1: Isolated flecks of plaque at the gingival margin Score 2: A continuous band of plaque up to 1mm at the gingival margin Score 3: Plaque greater than 1mm in width and covering up to one third of the tooth surface Score 4: Plaque covering from one thirds to two thirds of the tooth surface Score 5: Plaque covering more than two thirds of the tooth surface
Measured: baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Feb 2017
- Primary completion10 Mar 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculus, DentalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faleh Tamimi
- Sponsor type
- University, hospital or other
- Collaborators
- MedTeq, Mitacs, Visionaturolab INC., Cégep Garneau
- Responsible party
- Sponsor-investigator, Faleh Tamimi, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381403
- Sponsor's protocol ID
- A08-M35-16B
- Status last verified
- Jul 2020
- First submitted
- 30 Apr 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research team will collect the personal information of participants. This may include their name, address, phone number, health plan number, date of birth, dental and medical history, and medical-related information, which shall be collected from all participants by asking them to fill dental and medical history forms. All information collected from participants will be kept Confidential at the study site and secure in a locked file cabinet in Cégep Garneau. The electronically stored information would be also secured in a computer hard drive accessible only to researchers with a confidential access code. This information will be kept for 5 years after the study is terminated. All study data will also be sent to the sponsor and/or its representatives, as long as they agree to use the information as described previously. However, this data will not identify the participants by name.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Toothpaste for the Removal of Dental Calculus: a Double-blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04381403
- Acronym / sponsor ID
- A08-M35-16B
- Keywords
- Oral Hygiene, Calculus, Dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Faleh TamimiUniversity, hospital or other
- Collaborators
- MedTeq, Mitacs, Visionaturolab INC., Cégep Garneau
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 8 May 2020 (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.
Periodontal disease is amongst the most prevalent oral diseases worldwide and in North America. According to the 2007/09 Canadian Health Measures Survey, 16% of Canadian adults and 24% of older adults, 60 to 79 years of age, were found to have moderate periodontal disease. Moreover, 11% of Canadian adults were found to have calculus scores in the highest range. On the other hand, recent reports on the prevalence of periodontitis in the US showed that 47.2% of adults aged 30 years and older have some form of periodontal disease and 70.1% of adults 65 years and older have periodontal disease. The estimates also showed that the expenditure for periodontal treatments in the US is about approximately $ 14.3 billion.
Since dental calculus plays an important etiological role in initiation and progression of periodontal diseases. Investigation and investment on preventive technologies to prevent the periodontal disease are important for any health care system and its end-users. Furthermore, the removal and prevention of dental calculus using an effective toothpaste could reduce the need for professional periodontal interventions or the time of these treatments that in turn reduces their cost and other burdens on patients.
The aim of this study is to assess the efficacy of D-Tart toothpaste in removing dental calculus compared to Crest® (Complete Whitening plus Scope, tartar control, Procter \& Gamble, Cincinnati, OH), anti-tartar toothpaste with similar pH and texture to D- Tart toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-descaling D-Tart toothpaste | Experimental | Other: Bio-descaling D-Tart toothpasteBio-descaling D -Tart is a bio-descaler toothpaste that is manufactured at Du-Var laboratories (1460 Graham Bell, Boucherville, Québec, Canada J4B 6H5) |
| Crest® | Active comparator | Other: Crest® toothpasteanti-tartar toothpaste, Complete Whitening plus Scope, tartar control produced by Procter \& Gamble, Cincinnati, OH), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years and over, to ensure compliance with the study instructions
- Systemically healthy to exclude the possibility of calculus formation due to disease;
- Has at least 20 sound natural teeth including all lower anterior teeth, the main location of calculus build up;
- Having the history of previous calculus formation (at least 1.5 mm of calculus width) on the lingual surfaces of the mandibular anterior teeth after 3- 6 months of receiving a professional prophylaxis treatment, for better assessment of the toothpaste effectiveness;
- Agree to follow the study instruction: adherence to study arm, for the study timeline.
Key exclusion criteria (7 listed)
- Pregnancy: pregnant women at high risk of developing gum inflammation that usually occurs during pregnancy, which could introduce bias to the study;
- any physical handicap, psychological or health conditions that might jeopardize the ability of the patient to brush his/ her teeth, these complications cause bias in the study;
- Antibiotics or anti-inflammatory drugs are taken within 1 month prior to the study, to avoid bias when assessing the gum health;
- Currently using Chlorhexidine oral products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in our assessment of calculus removal by our toothpaste;
- Sensitivity to tartar-control toothpaste;
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 |
|---|---|---|
| Bio-descaling D-Tart toothpastePatients received Bio-descaling D-Tart toothpaste, which is a new dentifrice (Visionaturolab Inc., QC) that contains a natural bio-descaler powder of cuttlefish bone | Other | Bio-descaling D-Tart toothpaste |
| Crest® toothpastePatients received Crest toothpaste; Anti-tartar toothpaste | Other | Crest® |
Primary outcome
Change in calculus index
Time frame: Baseline, 3 months, 9 months
Calculus level in mm on teeth before and after brushing with toothpaste.
3 secondary outcomes
Modified Gingival Index
Time frame: Baseline, 3 months, 9 months
Shaw and Murray Stain Index
Time frame: baseline, 3 months, 9 months
Quigley-Hain plaque index (QHI)
Time frame: baseline, 3 months, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No. The research team will collect the personal information of participants. This may include their name, address, phone number, health plan number, date of birth, dental and medical history, and medical-related information, which shall be collected from all participants by asking them to fill dental and medical history forms. All information collected from participants will be kept Confidential at the study site and secure in a locked file cabinet in Cégep Garneau. The electronically stored information would be also secured in a computer hard drive accessible only to researchers with a confidential access code. This information will be kept for 5 years after the study is terminated. All study data will also be sent to the sponsor and/or its representatives, as long as they agree to use the information as described previously. However, this data will not identify the participants by name.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-descaling D-Tart toothpaste and Crest® toothpaste in people with Calculus, Dental and Periodontal Diseases, run by Faleh Tamimi at 1 site in Canada.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in calculus index (time frame: Baseline, 3 months, 9 months). 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 17 Jul 2020.