Gingivitis
Conditions
Keywords
Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt
Brief summary
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.
Interventions
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 was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
Sponsors
Osaka University
Tohoku University
Nihon University
Lion Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingival Index | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Redness | 3 months | Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva. |
| Gingivitis Severity Inedex | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| salivary antioxidant status | 3 months | Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP). |
Countries
Japan
Outcome results
None listed