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

Seoul St. Mary's Hospital

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Other: Bio Mineral toothpaste; Other: Perio Total Care toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT01548469

MIRUS_DENTAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 63 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Perio Total Care toothpaste

Active Comparator group

Description:

A Group which use Perio Total Care toothpaste during participation.

Treatment:

Other: Perio Total Care toothpaste

Bio Mineral toothpaste

Experimental group

Description:

A Group which use Bio Mineral toothpaste during participation.

Treatment:

Other: Bio Mineral toothpaste