Gingivitis, Periodontitis
Conditions
Brief summary
The aim of the present clinical study is to evaluate the efficacy and safety of the novel toothpaste in patients diagnosed with gingivitis and/or periodontitis.
Detailed description
The trial was a randomized, double-blind, placebo-controlled, parallel group, single-center(Department of periodontology, Yonsei University Dental Hospital) study. 98 patients were assessed for eligibility. Since two patients did not meet the inclusion criteria, 96 subjects were randomly assigned to either the test group.The test group was provided a liquid toothpaste and a control group received placebo. At the end of the study, results were analyzed for 87 patients : 42 in the test group and 45 in the control group . The study protocol requested 4 visits- once every two weeks-of each subjects in the center. At the baseline, subjects were randomly allocated to the test group or the control group. Scaling and tooth brushing instruction were performed and all of the clinical parameters were evaluated. At the 2- and 4-week examinations, clinical parameters of GI, PI were evaluated and at the 6-week examination, all of the clinical parameters were evaluated. Also, Microbiological quantitative analysis of this procedure was performed at the baseline and 6-week examinations.
Interventions
OTHERDA-5502 liquid toothpaste
6 weeks study, brush three times daily, liquid toothpaste
OTHERplacebo
same flavor solution, brush three times daily
Sponsors
Dong-A Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health. * Minimum of 20 uncrowned permanent natural teeth (excluding third molars). * Initial gingivitis index of 1.1\ 2.0 as determined by the use of the Loe and Silness Gingival Index. * Signed Informed Consent Form.
Exclusion criteria
* initial plaque index \<1.5, gingival index \<1.0 * smoker * Chronic disease (uncontrolled diabetes, liver disease, heart disease, kidney disease..) * subject who had hemorrhagic medical history or who take antiplatelet agent or anticoagulant * subject who need antibiotics for preventive administration * subjects who had preventive treatment or treatment for periodontitis in the last three months * Use of orthodontic appliances. * Pregnant women or women who are breast feeding. * Previous participation in any other clinical trial in the last 30 days * Judged unsuitable by investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gingival index | 6 week |
Secondary
| Measure | Time frame |
|---|---|
| Plaque index | 6 week |
| Clinical attachment level | 6 week |
| Bleeding of probing | 6 week |
| change of microbial growth | 6 week |
Outcome results
None listed