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Completed

NCT Number: NCT02102295

Effects of Antioxidant Dentifrice on Gingivitis

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nihon University Hospital, School of Dentistry at Matsudo, Matsudo, Chiba, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental toothpaste

Drug

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

Control toothpaste

Drug

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

Primary outcomes

  1. Gingival Index

    Time frame: 3 months

Secondary outcomes

  1. Gingivitis Severity Inedex

    Time frame: 3 months

  2. Gingival Redness

    Time frame: 3 months

    Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.

Other outcomes

  1. salivary antioxidant status

    Time frame: 3 months

    Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).

Sponsors and collaborators

Lead sponsor

Lion Corporation

Industry

Collaborators

  • Nihon University
  • Osaka University
  • Tohoku University

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 2, 2014
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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