Health Condition 1: K050- Acute gingivitis
Conditions
Interventions
None listed
Sponsors
Dr Vaibhav Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 35 years (Standard WHO Index Age Group to measure Oral Hygiene, Gingival Health) belonging to any gender. 2. Diagnosed with mild to moderate gingivitis, defined as a Modified Gingival Index (MGI) score between 1.0 and 2.5 3. Possess at least 20 natural teeth, excluding third molars 4. Able and willing to maintain their routine oral hygiene practices throughout the study duration 5. Provide written informed consent in their native or preferred language 6. Agree to abstain from the use of any other oral health care products, mouthrinses, or herbal supplements during the intervention period
Exclusion criteria
Exclusion criteria: 1. Presence of clinical signs of periodontitis (clinical attachment loss of 3 mm or more in at least two non-adjacent teeth) 2. Radiographic evidence of alveolar bone loss 3. History of antibiotic, anti-inflammatory, or corticosteroid use within the past 3 months 4. Current use of tobacco in any form (smoked or smokeless) 5. Pregnant or lactating women 6. Known allergy or hypersensitivity to any ingredient in the herbal formulation 7. Presence of systemic conditions that influence periodontal health (e.g., poorly controlled diabetes, autoimmune disorders, immunosuppressive states) 8. Use of any herbal, homeopathic, or Ayurvedic oral health products within 30 days before enrollment 9. Participation in another clinical trial within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Gingival Inflammation: Modified Gingival Index (MGI): This validated index will be used to assess gingival inflammation, focusing on redness, swelling, and bleeding tendency. The MGI provides a standardized, reproducible method for evaluating changes in gingival health and is particularly sensitive to interventions aimed at reducing inflammation.Timepoint: Primary outcome (Reduction in gingival inflammation measured by Modified Gingival Index) will be assessed at specific time points: Baseline (Day 0), 4 weeks (Day 28 3 days), and 8 weeks (Day 56 3 days). Additional assessments are planned at 12 weeks (Day 90 7 days) to evaluate the sustained effect. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes 1. Plaque Accumulation 2. Gingival Bleeding Tendency 3. Oral Malodor 4. Oral Hygiene Knowledge & Practices 5. Patient Acceptability & Tolerability.Timepoint: Plaque Accumulation: Baseline, 1 week, 21 days, 45 days, 3 months Gingival Bleeding Tendency: Baseline, 1 week, 21 days, 45 days, 3 months Oral Malodor: Baseline, 1 week, 21 days, 45 days, 3 months Oral Hygiene Knowledge & Practices: Baseline, 3 months Patient Acceptability & Tolerability: 3 months | — |
Countries
India
Contacts
Public ContactDr Vaibhav Kumar
Dr.G.D.Pol foundation, Y.M.T. Dental College and Hospital
Outcome results
None listed