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

Not Applicable

Completed

• Conditions: Gingivitis,Dental Plaque,Teeth Stains,Bad Oral Breath,Teeth Sensitivity

• Registration Number: CTRI/2018/01/011253
• Lead Sponsor: Manisha Sales

Brief Summary

This study was an open label, interventional, trial evaluating the safety and efficacy of Ayurvedic Dant manjan in 40 patients with Dental Health Conditions such as Gingivitis, Plaque, Teeth Stains, Bad Breath and Tooth Sensitivity that has been  conducted in single center in India. The primary outcome measure was Improvement in Dental Health Symptoms of Gingivitis as compared to baseline visit. The secondary outcome measures were Improvement in Dental Health Symptoms of Plaque, Teeth Stains, Bad Breath and Tooth Sensitivity as compared to baseline visit. Another secondary outcome measured was to assess the Adverse Event associated with the treatment. The results of this study demonstrate that the Ayurvedic Dant Manjan had a better efficacy profile, for the treatment of dental health problems such as gingivitis with bleeding gums, dental plaque, teeth stains, bad breath, tooth sensitivity as demonstrated by reduction of Gingival Index, Plaque Index, Lobene Stain Indices, Bad breath and Tooth Sensitivity at end of the Study Treatment and is safe and well tolerated.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Study Completion: 2017-11-28
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

• 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).

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The measurement of changes in the Gingival Index Score at the end of the study as compared to the baseline.	28 days

Secondary Outcome Measures

Name	Time	Method
Assessment of Adverse Events associated with the treatment.	28 days
The measurement of changes in the Quigley – Hein (Tuersky) Index Score of plaque at the end of the study as compared to the baseline.	28 days
The measurement of changes in the Lobene Index Score of stain at the end of the study as compared to the baseline.	28 days
The measurement of bad breath using organoleptic method.	28 days
The measurement of tooth sensitivity in patients who have sensitive teeth using tactile stimulus test	28 days

Trial Locations

Locations (1)

Holistic Health Care and Research Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Holistic Health Care and Research Centre

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Pradeep Balerao

Principal investigator

04024738805

vjyo2001@gmail.com