Effects of Antioxidant Dentifrice on Gingivitis
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|ClinicalTrials.gov Identifier: NCT02102295|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Drug: Experimental toothpaste Drug: Control toothpaste||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Active Comparator: Experimental toothpaste
L-ascorbic acid 2-phosphate magnesium salt / fluoride
Drug: Experimental toothpaste
Experimental toothpaste was containing 0.3% L-ascorbic acid 2-phosphate magnesium salt and 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
Other Name: L-ascorbic acid 2-phosphate magnesium salt toothpaste
Placebo Comparator: Control toothpaste
Drug: Control toothpaste
Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
Other Name: Fluoride toothpaste
- Gingival Index [ Time Frame: 3 months ]
- Gingivitis Severity Inedex [ Time Frame: 3 months ]
- Gingival Redness [ Time Frame: 3 months ]Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.
- salivary antioxidant status [ Time Frame: 3 months ]Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102295
|Nihon University Hospital, School of Dentistry at Matsudo|
|Matsudo, Chiba, Japan, 271-8587|
|Tohoku University Dental Hospital|
|Sendai, Miyagi, Japan, 980-8575|
|Osaka University Dental Hospital|
|Suita, Osaka, Japan, 565-0871|
|Nihon University Dental Hospital|
|Chiyoda-ku, Tokyo, Japan, 101-8310|
|Principal Investigator:||Shinya Murakami||Osaka University|