Clinical Study Examining the Control of Plaque and Gingivitis
ConditionGingivitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive
About this trial
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Disqualifiers
Presence of orthodontic bands.
Presence of partial removable dentures.
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
Silica Free Meridol
DrugToothpaste
Meridol
DrugToothpaste
Colgate Dental Product
DrugMFP fluoride toothpaste
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Test 1 toothpasteExperimental treatment 1 intervention
Group B: Test 2 toothpasteActive comparator 1 intervention
Group C: Test 3 toothpasteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gingivitis Assessment
A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth 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. 0 = Absence of inflammation 1. = Mild inflammation - slight change in color and little change in texture 2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy 3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.
Time frame
Baseline, 3 month, 6 month2
Quigley-Hein Plaque Index
First using a red solution to dye the plaque, a Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth 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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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