Trial | NCT02102295  Report issue

Title

Effects of Antioxidant Dentifrice on Gingivitis
Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival redness.
Study Started
Sep 30
2006
Primary Completion
Jul 31
2007
Study Completion
Jul 31
2007
Last Update
Apr 02
2014
Estimate

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 names: L-ascorbic acid 2-phosphate magnesium salt 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 names: Fluoride toothpaste

Experimental toothpaste Active Comparator

L-ascorbic acid 2-phosphate magnesium salt / fluoride

Control toothpaste Placebo Comparator

fluoride

Criteria 

Inclusion Criteria:

Age between ≥ 20 and < 65 y with at least 16 permanent teeth.
Gingival inflammation or mean baseline GI ≥ 0.5 without severe periodontal disease enough to require professional therapy.
Written informed consent to participate.

Exclusion Criteria:

Taking medications that could influence periodontal tissue health, such as antimicrobials and antihypertensives within 1 month before starting the trial.
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.
No Results Posted