Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Sun Pharma Industries Limited (SPIL)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (>=18 years) of either sex 2. Patients diagnosed with odontogenic infection [dental caries, periapical infection, periodontal disease (gingivitis and periodontitis), pericoronitis] 3. Patients prescribed with oral cephalexin-clavulanic acid FDC or other commonly prescribed antibiotics (amoxicillin-clavulanic acid FDC and cefuroxime) for the management of DIs
Exclusion criteria
Exclusion criteria: 1. Patients with incomplete records of the required study parameters 2. Patients with severe infections requiring parenteral antibiotics 3. Patients with a history of allergy or contraindications to study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients achieving clinical improvement from baseline to Day 10 of treatment period [Clinical improvement is defined as improvement or partial resolution of infectionrelated clinical signs and symptoms (a composite measure of pain, swelling, fever, and requirement of additional antimicrobial therapy) as per dentistâ??s judgment]Timepoint: Baseline to Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients achieving clinical improvement from baseline to Day 5 and Day 7 of the treatment period â?¢ Time to clinical improvement across treatment groups â?¢ Proportion of patients requiring addition of analgesics/NSAIDs â?¢ Proportion of patients requiring addition/change in antibiotics â?¢ Proportion of patients with adverse events across treatment groupsTimepoint: Baseline to Day 5 & Day 7 | — |
Countries
India
Contacts
Public ContactDr Chintan Khandhedia
Sun Pharma Industries Limited
Outcome results
None listed