A study to understand the effect of combination of antibiotics in Patients with Dental Infections in India
Not Applicable
- Conditions
- Health Condition 1: K088- Other specified disorders of teethand supporting structures
- Registration Number
- CTRI/2023/03/050320
- Lead Sponsor
- Sun Pharma Industries Limited (SPIL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ Proportion of patients achieving clinical improvement from baseline to Day 10 of treatment <br/ ><br>period [Clinical improvement is defined as improvement or partial resolution of infectionrelated <br/ ><br>clinical signs and symptoms (a composite measure of pain, swelling, fever, and <br/ ><br>requirement of additional antimicrobial therapy) as per dentistâ??s judgment]Timepoint: Baseline to Day 10
- Secondary Outcome Measures
Name Time Method â?¢ Proportion of patients achieving clinical improvement from baseline to Day 5 and Day 7 of <br/ ><br>the treatment period <br/ ><br>â?¢ Time to clinical improvement across treatment groups <br/ ><br>â?¢ Proportion of patients requiring addition of analgesics/NSAIDs <br/ ><br>â?¢ Proportion of patients requiring addition/change in antibiotics <br/ ><br>â?¢ Proportion of patients with adverse events across treatment groupsTimepoint: Baseline to Day 5 & Day 7