Clinical trial NCT01548469: Study to Evaluate Clinical Efficacy and Safety of Bio Mineral Toothpaste in Patients With Mild Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: Mild periodontitis
Bio Mineral toothpaste
Geumjin Thermal Water
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2012-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
timeFrame: 0 to 4 weeks
measure: Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
timeFrame: 0 to 4 weeks
Secondary outcomes:
measure: Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.
timeFrame: 0 to 4 weeks
measure: Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seocho-Gu
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seoul
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Youngkyung Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
References: