Skip to content

A Clinical Trial to assess the Efficacy and Safety of Ayurvedic Dant Manjan

An Open Label, Single arm, Monocentric Clinical Study to evaluate Efficacy and Safety of Ayurvedic Dant Manjan.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/01/011253
Enrollment
50
Registered
2018-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Gingivitis, Dental Plaque, Teeth Stains, Bad Oral Breath, Teeth Sensitivity

Interventions

Intervention1: Vithoba Ayurvedic Dant Manjan: Each 100 gm Contains: 1.Sodii biboras - 9 gm 2.Terminalia belerica - 10.5 gm 3.Sodii chloridum - 5.4 gm 4.Camphora - 1.5 gm 5.Caryophyllus aromaticus Linn

Sponsors

Manisha Sales
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Men and women (age 18-60 years) who are suffering with dental health problems 2)At least 20 natural teeth suitable for evaluation 3)Subjects having gingivitis with gingival index > 1 4)Subjects having dental plaque with plaque index of 2 or more 5)Able and willing to sign approved informed consent

Exclusion criteria

Exclusion criteria: 1)Females disagree to birth control measure for the duration of the study 2)Known allergy to constituents of the formulation of toothpowder. 3)Subjects with preexisting systemic diseases necessitating long term medications 4)Subjects having advanced Dental disease 5)Subjects having diseases of soft /hard tissues 6)Subjects Having fixed orthodontic appliances (including permanent orthodontic retainers) 7)Subjects with Abnormal salivary function 8)Having any acute /chronic systemic illness 9)Subjects who have the habit of consuming alcohol, smoking, chewing gums, pan or gutka. 10)Pregnant or lactating Females 11)Antibiotic use in the last 3 months 12)Routine use of anticoagulant medication 13)Routine use of anti-inflammatory medication 14)Routine use of medications known to have effects on the gingiva (e.g., phenytoin etc) 15)Routine use of medications inhibiting or stimulating salivary flow 16)Physical handicap that could interfere with daily performance of oral hygiene 17)Participation in any other study during the study period of this trial 18)Routine use of any mouthrinse 19)Routine use of any interdental cleaning device (floss, dental toothpicks) 20)Having probing depth >=4 mm at any site 21)Having had active periodontal therapy during the last 6 months 22)Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months 23)More than 3 carious lesions requiring immediate care 24)Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)

Design outcomes

Primary

MeasureTime frame
The measurement of changes in the Gingival Index Score at the end of the study as compared to the baseline.Timepoint: 28 days

Secondary

MeasureTime frame
Assessment of Adverse Events associated with the treatment.Timepoint: 28 days;The measurement of bad breath using organoleptic method.Timepoint: 28 days;The measurement of changes in the Lobene Index Score of stain at the end of the study as compared to the baseline.Timepoint: 28 days;The measurement of changes in the Quigley â?? Hein (Tuersky) Index Score of plaque at the end of the study as compared to the baseline.Timepoint: 28 days;The measurement of tooth sensitivity in patients who have sensitive teeth using tactile stimulus testTimepoint: 28 days

Countries

India

Contacts

Public ContactKamal Kammili

Sanjeevani Bio Services Pvt. Ltd.

srinivas.lanka@sanjeevanibio.com04065794774

Outcome results

None listed

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