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

This study has been completed.
Sponsor:
Collaborator:
The Catholic University of Korea
Information provided by (Responsible Party):
Youngkyung Ko, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01548469
First received: March 5, 2012
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Periodontitis
Other: Bio Mineral toothpaste
Other: Perio Total Care toothpaste
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline. [ Time Frame: 0 to 4 weeks ] [ Designated as safety issue: No ]
    Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.

  • Changes in score of "Modified Gingival Index" at 4 weeks from baseline. [ Time Frame: 0 to 4 weeks ] [ Designated as safety issue: No ]
    Changes in score of "Modified Gingival Index" at 4 weeks from baseline.


Secondary Outcome Measures:
  • Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline. [ Time Frame: 0 to 4 weeks ] [ Designated as safety issue: No ]
    Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.

  • Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

    Questionnaire Item

    1. Elimination of plaque
    2. Feeling of refreshment
    3. Amount of bubble.
    4. Feeling of flow.
    5. Taste and Flavor.
    6. Level of cleansing teeth
    7. Creamy consistency

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



Enrollment: 60
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Perio Total Care toothpaste
A Group which use Perio Total Care toothpaste during participation.
Other: Perio Total Care toothpaste
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Other Name: Perio Total Care toothpaste
Experimental: Bio Mineral toothpaste
A Group which use Bio Mineral toothpaste during participation.
Other: Bio Mineral toothpaste
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
Other Name: Bio Mineral toothpaste

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Who has history of using antimicrobials or antibiotics during the past 30 days.
  2. Who has history of periodontal treatment during the past 30 days.
  3. Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
  4. Who has hypersensitive conditions caused by Gingivitis or periodontitis.
  5. Who having restorative dentistry or wearing braces widely.
  6. Who using tobacco products (Except for who quit smoking)
  7. Who has been participated in other clinical trials during the past 4 weeks.
  8. Who judged inappropriate to participate in the study by investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548469

Locations
Korea, Republic of
Seoul St.Mary's Hospital
Seocho-Gu, Seoul, Korea, Republic of, 137701
Sponsors and Collaborators
Seoul St. Mary's Hospital
The Catholic University of Korea
Investigators
Principal Investigator: Youngkyung Ko, M.D. Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Youngkyung Ko, Assistant professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01548469     History of Changes
Other Study ID Numbers: MIRUS_DENTAL
Study First Received: March 5, 2012
Last Updated: February 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul St. Mary's Hospital:
Mild periodontitis
Bio Mineral toothpaste
Geumjin Thermal Water

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014