This is a clinical trial wherein the efficacy and safety of Curcumin will be studied in Canker sore and gingivitis.
- Conditions
- Health Condition 1: K05- Gingivitis and periodontal diseasesHealth Condition 2: K137- Other and unspecified lesions of oral mucosa
- Registration Number
- CTRI/2017/01/007670
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1 Healthy male and or female with no systemic disease.
2 Age between 18 to 60 years.
3 Having mouth ulcers with throat pain or Patients with mild to moderate gingivitis.
4 Patients having erupted teeth.
5 Willing to come for regular follow-up visits.
6 Able to give written informed consent.
1 Smokers.
2 Presence of any systemic hematological problems.
3 Drug or alcohol abuse.
4 Under systemic or topical corticosteroid therapy.
5 Pregnant women or lactating mothers
6 History of HIV and other viral infections.
7 History of any antibiotic therapy in past 3 months.
8 History of oral prophylaxis within 6 months previous to the study
9 Patients with mouth breathing habit.
10 Patients using orthodontic and prosthodontics appliances
11 Are on analgesics or antiseptics.
12 Patients who have received any periodontal therapy in the past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For Canker sore with throat pain - Number of ulcers healed,VAS Pain Scale,Ulcer size reduction,Duration of complete healing of ulcers, <br/ ><br>Clinical Photographs of the Lesion,Throat Numbness Scale,Sore Throat Relief Scale(Screening,Day14 & Day21). <br/ ><br> <br/ ><br>For Gingivitis -Loe and Silness Gingival index,Subjective and objective criteria for Gingivitis. <br/ ><br>â?¢Clinical Photographs of gingival region.Timepoint: For Canker sore with throat pain - Number of ulcers healed,VAS Pain Scale,Ulcer size reduction, Duration of complete healing of ulcers, Clinical Photographs of the Lesion,Throat Numbness Scale,Sore Throat Relief Scale (Screening,Day14 & Day21). <br/ ><br> <br/ ><br> <br/ ><br>For Gingivitis - Loe and Silness Gingival index, Subjective and objective criteria for Gingivitis,Clinical Photographs of gingival region(Screening,Day14 & Day 21).
- Secondary Outcome Measures
Name Time Method â?¢Any reports of adverse or serious adverse events. <br/ ><br>â?¢Abnormal vital signs& lab parameters.Timepoint: â?¢Any reports of adverse or serious adverse events(Day 14 & Day 21). <br/ ><br>â?¢Abnormal vital signs (Screening,Day 14 & Day 21)& <br/ ><br>lab parameters (Screening & Day 21).