Health Condition 1: K055- Other periodontal diseases
Conditions
Interventions
Intervention1: DENTORA�® GEL: GEL as a thin layer on the gums twice daily using a finger or swab.(As applicable)
The treatment duration will be 7 days
Control Intervention1: Metrogyl Denta: GEL as
Sponsors
AGIO PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both males and Females of Age � 6 years to 50, without any known allergy to commercial dental products or cosmetics. 2.Subject who meets with anyone of the following Infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity
Exclusion criteria
Exclusion criteria: 1.Subjects who report history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease , chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients. 2.Subjects with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity. 3.Subjects with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain. 4.Long-term daily use more than 7 consecutive days of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Evaluation of Tooth sensitivity reduction in Mean Cold Air VAS Stimulus Score using Heft parker Visual Analog Scale 2. Evaluation of Reduction in gingivitis levels (bleeding on probing) assessed by the Gingival Bleeding Index (GBI)Timepoint: baseline day1 day 5, day 7 and day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of the changes in deep tooth stains from screening to EOT by Lobene Stain index 2.Evaluation of the changes in tooth mobility for loose tooth roots from screening to EOT by mobility grading 3.Improvement in overall oral health performance is assessed by Oral Health Assessment Tool for Dental Screening and Oral care Assessment Guide 4.Incidence and Rate of adverse eventsTimepoint: baseline day1 day 5, day 7 and day 10 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed