Health Condition 1: K05- Gingivitis and periodontal diseases Health Condition 2: K137- Other and unspecified lesions of oral mucosa
Conditions
Interventions
Intervention1: C3 Reduct ODN.: One tablet of C3 Reduct ODN twice daily in the treatment of Canker sore with throat pain and Gingivitis.
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). For Gingivitis -Loe and Silness Gingival index,Subjective and objective criteria for Gingivitis. 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). For Gingivitis - Loe and Silness Gingival index, Subjective and objective criteria for Gingivitis,Clinical Photographs of gingival region(Screening,Day14 & Day 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Any reports of adverse or serious adverse events. â?¢Abnormal vital signs& lab parameters.Timepoint: â?¢Any reports of adverse or serious adverse events(Day 14 & Day 21). â?¢Abnormal vital signs (Screening,Day 14 & Day 21)& lab parameters (Screening & Day 21). | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
ClinWorld(P)Limited
Outcome results
None listed