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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548469
• Other study ID #: MIRUS_DENTAL
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2012
• Last updated: February 5, 2013
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 63 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Bio Mineral toothpaste
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
• Perio Total Care toothpaste
Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seocho-Gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No