An initial study for checking the effectiveness of an ayurvedic toothpaste in dirt removal from the teeth and gum disease.

Active, not recruiting

Conditions: Chronic gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH,

Registration Number: CTRI/2022/07/044225

Lead Sponsor: Dr Anudarsh PK

Brief Summary: This is a pilot study to evaluate the effectiveness of herbal tooth paste on dental plaque and gingival health against commercially available tooth paste. Before the start of the study, written consent will be taken from the patients. A total sample of 60 volunteers will be included in the study. The 60 volunteers will be assigned randomly into two groups, namely Group A, i.e. the Control group and Group B i.e. the Test group equally. 30 volunteers in Group A will receive Colgate with amino shakti tooth paste as control and 30 volunteers in Group B will receive Edinora prime tooth paste. All the study participants will receive a Colgate medium tooth brush for brushing. Participants will be advised to brush twice daily for 2-3 minutes, using pea size amount of tooth paste. The weight of tooth paste will be measured and recorded on the first visit before the distribution and on the last visit. On the first visit participants will be asked to report in the morning, i.e., approximately 12 hours after oral hygiene for baseline sampling. Oral examination will be carried out and dental plaque will be assessed using modified Quigley Hein plaque index and gingivitis will be scored using Loe H & Silness P gingival index. After the oral examination, demonstration of modified bass method of brushing will be given using a study model and later the tooth paste and tooth brush will be distributed based on the assigned group. The oral examination will be conducted by trained dentist and the dentist will be blinded. Plaque disclosing agent will be used for scoring the dental plaque. The second visit will be on the 15th day after the initial visit and plaque index and gingival index will be recorded. The final visit will be on the 30th day and plaque index and gingival index will be recorded and the participants will be asked to return the remaining tooth paste to the researcher. All the study participants will be blinded throughout the study. The collected data will be used for statistical analysis and the statistician will be blinded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 60

Inclusion Criteria

Individuals who are willing to participate in the study.
Males and females in good general health aged 18 to 30 years available for the duration of the study.
A minimum of 20 natural teeth with facial and lingual scorable surfaces.

Exclusion Criteria

Individuals who are under antibiotics or anti-inflammatory drugs.
History of dental prophylaxis or treatments in the past month.
Individuals undergoing orthodontic treatment.
History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases.
Individuals with oral soft tissue pathology.
History of active or severe periodontal disease with bleeding gums and loose teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dental plaque and gingival health will be assessed using modified Quigley Hein plaque index and Loe H & Silness P gingival index respectively.	baseline data on 1st day and second assessment on 15th day and final data collection on 30th day.

Secondary Outcome Measures

Name	Time	Method
Oral hygiene will be assessed	at the 15th day and 30th day

Trial Locations

Locations (1): COORG INSTITUTE OF DENTAL SCIENCES
🇮🇳
Kodagu, KARNATAKA, India
COORG INSTITUTE OF DENTAL SCIENCES
🇮🇳Kodagu, KARNATAKA, India
Dr Anudarsh PK
Principal investigator
8925129213
itsmedarsh25@gmail.com