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

NCT04381403 | Completed

• 1 other identifier: A08-M35-16B
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Calculus, Dental; Periodontal Diseases; Periodontal Inflammation

Keywords

Oral Hygiene; Calculus; Dental plaque

Outcome Measures

Primary Outcomes (1)

• Change in calculus index

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

  Baseline, 3 months, 9 months

Secondary Outcomes (3)

• Modified Gingival Index

  Baseline, 3 months, 9 months

• Shaw and Murray Stain Index

  baseline, 3 months, 9 months

• Quigley-Hain plaque index (QHI)

  baseline, 3 months, 9 months

Study Arms (2)

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)

Other: Bio-descaling D-Tart toothpaste

Crest®

ACTIVE COMPARATOR

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

Other: Crest® toothpaste

Interventions

Bio-descaling D-Tart toothpaste OTHER

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

Bio-descaling D-Tart toothpaste

Crest® toothpaste OTHER

Patients received Crest toothpaste; Anti-tartar toothpaste

Crest®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faleh Tamimi: lead
• MedTeq: collaborator
• Mitacs: collaborator
• Visionaturolab INC.: collaborator
• Cégep Garneau: collaborator

Study Sites (1)

McGill University Faculty of Dentistry

Montreal, Quebec, H3A 1G1, Canada

Location

MeSH Terms

Conditions

Dental Calculus; Periodontal Diseases; Calculi; Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: February 1, 2017
• Primary Completion: March 10, 2019
• Study Completion: April 30, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)