A clinical trial to compare the effects of an Unani Toothpaste with Herbo-mineral Toothpaste in patients with infection of gums that support the teeth
- Conditions
- Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
- Registration Number
- CTRI/2023/03/050322
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy male and non-pregnant female
2. Aged between 18 and 65 years.
3. Willing to give signed written informed consent
4. Subjects having AmrÄ?d al-AsnÄ?n (disease of the teeth) with or without any of the following symptoms:
Bakhr al-Fam (halitosis)
Quruh al-Litha (gingival ulcer)
Taharruk al-Asnan (odontoseisis)
Waram al-Lissa (gingival swelling)
Humra al-Lissa (gingival erythema)
Nazf al-Lisa (gingival bleeding)
Dhahab Maâ?? al-Asnan (sensitive teeth)
Wajaâ?? al-AsnÄ?n (toothache)
1. Requirement for prophylactic antibiotic medication,
2. Unable to comply with a study schedule,
3. Untreated caries
4. Periodontitis requiring prompt treatment or
5. Emergency dental treatment,
6. Wearing any kind of oral appliance,
7. History of known allergies
8. Known case of Hemophilia, Low platelet count (thrombocytopenia) and von Willebrand disease (VWD), etc.
9. Known cases of any other acute illness.
10. Known cases of systemic disorders requiring prolonged treatment.
11. Pregnant and lactating women.
12. History of Hypersensitivity to the study drug or any of its ingredients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in sign and symptoms of AmrÄ?d Al-AsnÄ?n-o-Litha (Periodontal Diseases) on the basis of VAS scoring. The bleeding will be scored as per Modified Sulcus Bleeding Index Scoring Criteria.Timepoint: At baseline, 14th day and 28th days.
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessmentTimepoint: At baseline and end of the treatment i.e. after 28days