Effects of Antioxidant Dentifrice on Gingivitis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Experimental toothpaste
* Drug: Control toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental toothpaste<br>L-ascorbic acid 2-phosphate magnesium salt / fluoride | Drug: Experimental toothpaste<br>* 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.<br>* Other names: L-ascorbic acid 2-phosphate magnesium salt toothpaste;|
| Placebo Comparator: Control toothpaste<br>fluoride | Drug: Control toothpaste<br>* Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.<br>* Other names: Fluoride toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis Severity Inedex |  | 3 months | 
| Gingival Redness | Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt