Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive
About this trial
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months and six months of product use. All subjects will be followed for adverse events throughout the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the study.
Good general health.
Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
Disqualifiers
Orthodontic bands.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility), and/or
Extensive loss of periodontal attachment or alveolar bone.
Trial design
Design model
Parallel
Treatments tested in this trial
0.45% SnF HW with NaF (1450 F)
Drugtoothpaste
67% Bicarbonate with NaF (1400 F)
Drugtoothpaste
Colgate Cavity Protection Toothpaste
DrugToothpaste with MFP/NaF (1450 F)
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Test 1 toothpasteExperimental treatment 1 intervention
Group B: Positive ControlActive comparator 1 intervention
Group C: Negative ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lobene Modified Gingivitis Assessment
Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored
Time frame
Baseline, 3 month, 6 month2
Saxton Gingival Bleeding Assessment
Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing
Time frame
Baseline, 3 month, 6 month3
Modified Quigley-Hein Plaque Index
First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
Time frame
Baseline, 3 month, 6 monthSponsors and contacts
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Source ClinicalTrials.gov