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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Other: Perio Total Care toothpaste; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Seocho-Gu, Seoul, Korea, Republic of, 137701
      • Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.	Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.	0 to 4 weeks
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.	Changes in score of "Modified Gingival Index" at 4 weeks from baseline.	0 to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.	Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.	0 to 4 weeks
Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.	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).	4 weeks

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: The Catholic University of Korea
• Investigators: Principal Investigator: Youngkyung Ko, M.D., Seoul St. Mary'S Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Mild periodontitis; Bio Mineral toothpaste; Geumjin Thermal Water
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: MIRUS_DENTAL