A Phase 3 interventional study of Chlorhexidine toothpaste and Toothbrush in Gingivitis, Gingivitis and Periodontal Diseases and Gingival Disease, sponsored by Colgate Palmolive. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment
This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days.
This clinical study aims to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It is a Phase III study designed as randomized, one-center, double blind, parallel group trial involving 80 participants aged 18 to 70. Subjects will be divided into two groups: test group - subjects assigned to use a toothpaste with a 0.3% chlorhexidine + 3% AmCl and brush with a commercially available adult soft bristle toothbrush; negative control group - subjects assigned to use a placebo toothpaste without chlorhexidine and AmCl and brush with a commercially available adult soft bristle toothbrush. Subjects will undergo baseline, 14 days and 21 days evaluations. The primary outcome will be reduction of gingival inflammation and data will be analyzed using ANCOVA to assess the efficacy of the test product. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of the chlorhexidine toothpaste regarding gingivitis and dental plaque control.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 80 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
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Exclusion Criteria:
Test group assigned to use a 0.3% chlorhexidine + 3% AmCl toothpaste and brushing with a commercially available adult soft bristle toothbrush
Drug: Chlorhexidine toothpaste · Device: Toothbrush
Negative Control group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush
Device: Toothbrush · Drug: Placebo toothpaste without chlorhexidine and AmCl
A toothpaste containing 0.3% chlorhexidine + 3% AmCl
Commercially available adult soft bristle toothbrush
Negative Control Group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush.
Löe-Silness Gingival Index
A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable 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 scorable surface and dividing that number by the total number of surfaces scored.
Time frame: 21 days
Modified Quigley-Hein Plaque Index
The Turesky modification of the Quigley-Hein Plaque Index is a method for assessing dental plaque accumulation by scoring plaque presence on six surfaces of each tooth on a scale from 0 to 5.
Time frame: 21 days
Lobene Stain index
The labial/lingual surface of each tooth will be divided into two regions: the gingival region, and the body region. The gingival and body regions would be scored separately for yellow stains by use criteria for intensity or severity: 0- no stain, 1- light stain, 2-moderate stain, and 3-heavy stain. The extent to which these yellow stains covered the gingival and body regions will be scored: 0-no stain detected, only tooth color, 1- stain covering up to 1/3 of the region, 2- stain covering from 1/3 to 2/3 of the region, and 3- stain over two thirds of the region. The sum of the stain scores for a subject will be used as that subject's stain score.
Time frame: 21 days
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Colgate Palmolive