Effects of Antioxidant Dentifrice on Gingivitis

Lion Corporation

Status and phase: Completed; Phase 3

Conditions: Gingivitis

Treatments: Drug: Control toothpaste; Drug: Experimental toothpaste

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02102295

LionSDP-6

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

Experimental toothpaste

Active Comparator group

Description:

L-ascorbic acid 2-phosphate magnesium salt / fluoride

Treatment:

Drug: Experimental toothpaste

Control toothpaste

Placebo Comparator group

Description:

fluoride

Treatment:

Drug: Control toothpaste