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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

A Single-Blind, Randomized, Parallel-Group Study to Compare Safety and Efficacy of an Unani Toothpaste with Herbo-mineral Toothpaste in Patients with AmrÄ?d Al-AsnÄ?n-o-Litha (Periodontal Diseases)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050322
Enrollment
60
Registered
2023-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Sunoon-E-Musatahkam-E-Dandan (Unani Toothpaste) : Use sufficient quantity (Paste) of toothpaste for brushing of teeth with Toothbrush Control Intervention1: Dant-Rakshak (Herbo-minera

Sponsors

Central Council for Research in Unani Medicine CCRUM New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Haematological and biochemical assessment for safety assessmentTimepoint: At baseline and end of the treatment i.e. after 28days

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026