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

Phase 3

Not yet recruiting

• Conditions: 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

This study is designed as a single blind randomized parallel group trial in patients with **AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases)**.  Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Sunoon-E-Musatahkam-E-Dandan (Unani Toothpaste)or Dant-Rakshak (Herbo-mineral Toothpaste)  as allocated by randomization method. The total duration of treatment will be 28 days and the follow-up for all clinical parameters will be conducted on baseline, 14th and 28th day.

**Rationale of study:**

The Unani formulation *Sunoon-e-Musatahkam-e-Dandan* SMD (Unani Toothpowder) was developed into toothpaste by NIPERHyderabad and preclinical safety study of the Unani Toothpaste (*Sunoon-e-Musatahkam-e-Dandan*) was also carried out by NIPER Hyderabad.   This study has been designed to assess thesafety and efficacy of the Unani Toothpaste (SMD) in healthy volunteers. TheSMD has been described in NFUM and itsactions as mentioned are *Dafi‘-i-Ta‘affun* (antiseptic)*, Habis-i-Dam* (hemostyptic)**.**It is recommended to use in the conditions like*Bakhr al-Fam* (halitosis),*Quruh al-Litha* (gingival ulcer), *Taharruk al-Asnan*(odontoseisis). The SMD is an Unani formulationcontaining herbs and minerals which possess the *Dafi‘-i-Ta‘affun* (antiseptic),*Muhallil Waram* (resolvent of inflammation),*Mujaffif*(desiccant), *Muqawwi-i-A‘sab* (nervine tonic)*, Muqawwiyat-i-Asnan-o-Litha* (tonics for gums and teeth)*,**Musakkin-i-Alam* (analgesic) activities [Anonumous,2006].

The *Sunoon-e-Musatahkam-e-Dandan* has been in use for thetreatment of *Bakhral-Fam*(halitosis), *Quruh al-Litha* (gingival ulcer), and *Taharruk al-Asnan*(odontoseisis) since long by eminent Unani physicians. Therefore, this study isundertaken to validate the safety and efficacy of Unani Toothpowder which is amodified dosage form of SMD to promote its use in the general public.

**Composition of Unani Toothpaste:**

| | | | |

| --- | --- | --- | --- |

|**S. No**

**Unani Name (scientific name)**

**Role**

**Quantity**

|1

Mastagi (*Pistacia lenticus* L.)

Gum/resin

4 parts

|2

Namak-e-Sambhar (Sambhar Lake salt)

Salt

4 parts

|3

Kath Safaid (*Acacia leucophloea* Willd.)

White catechu

4 parts

|4

Filfil Siyah (*Piper nigrum* L.)

Seed

4 parts

|5

Azaraqi Sokhta (*Strychnos nuxvomica* L.)

Seed

4 parts

|6

Shibb-e-Yamani Biryan (Alum)

Roasted alum

4 parts

|7

Tutiya (Copper sulphate)

Blue vitriol

1 part

|8

Sodium Chloride

Salt

TBD

|9

Dicalcium phosphate

Abrasive

TBD

|10

Calcium carbonate

Abrasive

TBD

|11

Glycerin

Humectant

TBD

|12

Gum tragacanth

Thickening agent

TBD

|13

Saccharine

Sweetener

TBD

|14

Sodium lauryl sulphate

Surfactant

TBD

|15

Methylparaben

Preservative

TBD

|16

Propylparaben

Preservative

TBD

|17

Flavoring agent

Flavoring agent

TBD

|18

Distilled water

Solvent

TBD

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-03
• Study Start: 2023-09-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy male and non-pregnant female 2.
• Aged between 18 and 65 years.
• Willing to give signed written informed consent 4.
• Subjects having AmrÄd al-AsnÄn (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 Ma’ al-Asnan (sensitive teeth) Waja‘ al-AsnÄn (toothache).

Exclusion Criteria

• 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.
• Known cases of any other acute illness.
• Known cases of systemic disorders requiring prolonged treatment.
• Pregnant and lactating women.
• 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 AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases) on the basis of VAS scoring. The bleeding will be scored as per Modified Sulcus Bleeding Index Scoring Criteria.	At baseline, 14th day and 28th days.

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline and end of the treatment i.e. after 28days

Trial Locations

Locations (1)

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad; 🇮🇳 Hyderabad, TELANGANA, India

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad

🇮🇳Hyderabad, TELANGANA, India

Dr Arzeena Jabeen

Principal investigator

9032519286

aarzu763@gmail.com