Gingivitis
Conditions
Keywords
gingivitis, localized treatment
Brief summary
The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients \[5 cycles\], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.
Interventions
DRUGperiopatch
Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 -75. 2. Severe localized gingival inflammation \[GI index 2 or greater
Exclusion criteria
1. Pregnancy or a wish to become pregnant during the study. 2. History of periodontal treatment within the last month. 3. Antibiotic treatment within the last month 4. Use of any antimicrobial mouthrinse within the last month. 5. Participation in another trial one month prior to the study. 6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments. 7. Systemic Disease. 8. Patients using salicylate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the correct dosing of the herbal Patch [THPP] | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| To demonstarte the safety of THPP on the gingival tissue and in the oral cavity | 3 months |
Countries
Israel
Outcome results
None listed