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Completed

NCT Number: NCT01548469

Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis

The hypothesis of this study is that using "Bio Mineral" toothpaste for 4 weeks will decrease plaque and gingivitis of mild periodontitis patients compared to patients using "Perio Total Care" toothpaste.

This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul St.Mary's Hospital

Seocho-Gu, Seoul, 137701, South Korea

About this study

This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis. 30 patients of treatment group and 30 patients of control group, total 60 patients will be enrolled to this study. Every patients will use investigational toothpaste 2 times everyday for 4 weeks and brush their teeth at least 3 minutes each time with 1ml of toothpaste.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A healthy man or menopausal woman who is at least 18 to maximum 63 years of age.
  • Agreed to participate voluntarily in the study.
  • Must have over 20 maxillary teeth
  • Must have mild periodontal disease which can induce mild plaque.
  • Having no general disease except for dental disease.
  • Must be able to understand and carry out the trial's objective and method.

Exclusion criteria

  • Who has history of using antimicrobials or antibiotics during the past 30 days.
  • Who has history of periodontal treatment during the past 30 days.
  • Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
  • Who has hypersensitive conditions caused by Gingivitis or periodontitis.
  • Who having restorative dentistry or wearing braces widely.
  • Who using tobacco products (Except for who quit smoking)
  • Who has been participated in other clinical trials during the past 4 weeks.
  • Who judged inappropriate to participate in the study by investigator

Treatment and study plan

Bio Mineral toothpaste

Other

Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once

Perio Total Care toothpaste

Other

Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once

Primary outcomes

  1. Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.

    Time frame: 0 to 4 weeks

    Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.

  2. Changes in score of "Modified Gingival Index" at 4 weeks from baseline.

    Time frame: 0 to 4 weeks

    Changes in score of "Modified Gingival Index" at 4 weeks from baseline.

Secondary outcomes

  1. Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.

    Time frame: 0 to 4 weeks

    Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.

  2. Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.

    Time frame: 4 weeks

    Compare Satisfaction of treatment group with Control Group at 4 weeks using Satisfaction Questionnaire.

    Questionnaire Item

    • Elimination of plaque
    • Feeling of refreshment
    • Amount of bubble.
    • Feeling of flow.
    • Taste and Flavor.
    • Level of cleansing teeth
    • Creamy consistency

    Each subjects will rate score 0(Very dissatisfied) to 10(Very satisfied) using VAS(Visual Analog Scale).

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • The Catholic University of Korea

Registry information

Official study title

Single Blind, Randomized, Active-controlled Comparative Clinical Trial to Evaluate Clinical Efficacy and Safety Following the Application for 4 Weeks of Bio Mineral Toothpaste in Patients With Mild Periodontitis

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Feb 6, 2013

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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