Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-09-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental toothpaste
L-ascorbic acid 2-phosphate magnesium salt / fluoride
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.
Control toothpaste
fluoride
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gingival inflammation or mean baseline GI ≥ 0.5 without severe periodontal disease enough to require professional therapy.
* Written informed consent to participate.
Exclusion Criteria
* Use of orthodontic appliances.
* Pregnancy or planning to become pregnant during the trial period.
* Previous participation in any other clinical trial.
* Inability of patient to understand the study purpose and/or study protocols.
* Judged unsuitable by investigators for other reasons.
20 Years
65 Years
ALL
Yes
Sponsors
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Osaka University
OTHER
Tohoku University
OTHER
Nihon University
OTHER
Lion Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Shinya Murakami
Role: PRINCIPAL_INVESTIGATOR
Osaka University
Locations
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Nihon University Hospital, School of Dentistry at Matsudo
Matsudo, Chiba, Japan
Tohoku University Dental Hospital
Sendai, Miyagi, Japan
Osaka University Dental Hospital
Suita, Osaka, Japan
Nihon University Dental Hospital
Chiyoda-ku, Tokyo, Japan
Countries
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References
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Shimabukuro Y, Nakayama Y, Ogata Y, Tamazawa K, Shimauchi H, Nishida T, Ito K, Chikazawa T, Kataoka S, Murakami S. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial. J Periodontol. 2015 Jan;86(1):27-35. doi: 10.1902/jop.2014.140138.
Other Identifiers
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LionSDP-6
Identifier Type: -
Identifier Source: org_study_id
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