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Development of a New Toothpaste for the Removal of Dental Calculus.

Primary Purpose

Calculus, Dental, Periodontal Diseases, Periodontal Inflammation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bio-descaling D-Tart toothpaste
Crest® toothpaste
Sponsored by
Faleh Tamimi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calculus, Dental focused on measuring Oral Hygiene, Calculus, Dental plaque

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • McGill University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bio-descaling D-Tart toothpaste

Crest®

Arm Description

Bio-descaling D -Tart is a bio-descaler toothpaste that is manufactured at Du-Var laboratories (1460 Graham Bell, Boucherville, Québec, Canada J4B 6H5)

anti-tartar toothpaste, Complete Whitening plus Scope, tartar control produced by Procter & Gamble, Cincinnati, OH),

Outcomes

Primary Outcome Measures

Change in calculus index
Calculus level in mm on teeth before and after brushing with toothpaste.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
April 30, 2020
Last Updated
July 15, 2020
Sponsor
Faleh Tamimi
Collaborators
MedTeq, Mitacs, Visionaturolab INC., Cégep Garneau
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1. Study Identification

Unique Protocol Identification Number
NCT04381403
Brief Title
Development of a New Toothpaste for the Removal of Dental Calculus.
Official Title
Development of Toothpaste for the Removal of Dental Calculus: a Double-blind, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 10, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faleh Tamimi
Collaborators
MedTeq, Mitacs, Visionaturolab INC., Cégep Garneau

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calculus, Dental, Periodontal Diseases, Periodontal Inflammation
Keywords
Oral Hygiene, Calculus, Dental plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bio-descaling D-Tart toothpaste
Arm Type
Experimental
Arm Description
Bio-descaling D -Tart is a bio-descaler toothpaste that is manufactured at Du-Var laboratories (1460 Graham Bell, Boucherville, Québec, Canada J4B 6H5)
Arm Title
Crest®
Arm Type
Active Comparator
Arm Description
anti-tartar toothpaste, Complete Whitening plus Scope, tartar control produced by Procter & Gamble, Cincinnati, OH),
Intervention Type
Other
Intervention Name(s)
Bio-descaling D-Tart toothpaste
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Crest® toothpaste
Intervention Description
Patients received Crest toothpaste; Anti-tartar toothpaste
Primary Outcome Measure Information:
Title
Change in calculus index
Description
Calculus level in mm on teeth before and after brushing with toothpaste.
Time Frame
Baseline, 3 months, 9 months
Secondary Outcome Measure Information:
Title
Modified Gingival Index
Description
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
Time Frame
Baseline, 3 months, 9 months
Title
Shaw and Murray Stain Index
Description
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.
Time Frame
baseline, 3 months, 9 months
Title
Quigley-Hain plaque index (QHI)
Description
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
Time Frame
baseline, 3 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
McGill University Faculty of Dentistry
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

Development of a New Toothpaste for the Removal of Dental Calculus.

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