Toothpaste with Babool Extract in Calcium carbonate base.
Mode of Usage: Apply a 2-3g (Full length brush amount) of toothpaste on the toothbrush bristles. Angle the toothbrush at 45 degrees to your gums and gently move it back and forth to clean your front teeth
Frequency: Twice a Day, (Morning and Before Bed)
Route of administration: Topical
Dosage Form: Paste
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
for 180 days
Intervention
Toothpaste with Miswak/Peelu Extract in Calcium carbonate base.
Mode of Usage: Apply a 2-3g (full length brush amount) of toothpaste on the toothbrush bristles. Angle the toothbrush at 45 degrees to your gums and gently move it back and forth to clean your front teeth.
Frequency: Twice a Day, (Morning and Before Bed)
Route of administration: Topical
Dosage Form: Paste
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight. for 180 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Age: 18 to 65 years (both inclusive) old at the time of consent.
2) Sex: Healthy adult males and non-pregnant/non-lactating females.
3) Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
4) Subjects are generally in good general health as determined from recent medical history.
5) Subjects with a plaque index, gingivitis, mild hypersensitive tooth, root carries during screening.
6) Subjects having 6 present upper front teeth.
7) Anterior teeth without restorations.
8) No previous treatments performed on tooth within last 90 days.
9) Subjects who agree to discontinue the use of over-the-counter any teeth products throughout the trial.
10) Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
11) Subjects who agree not to participate in any other oral/dental product studies during the trial.
12) Subjects who agree to return for all scheduled visits and follow study procedures.
13) Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements
ExclusionCriteria
Details
1) Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
2) Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
3) Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
4) Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
5) Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
6) Subjects have meaningful malocclusion that would impact treatment or ease of viewing/scoring anterior teeth.
7) Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
8) Subjects have any known allergies to over-the-counter oral hygiene/ products.
9) Subjects have any known allergies to the trial product ingredients.
10) The subject must have participated in a clinical study with oral care or oral hygiene within 4 weeks before the screening visit of this study.
11) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion
12) Subjects who smoke and are pan eaters.
13) Subjects with hypersensitive teeth and with mobility greater than one as per miller tooth mobility index.
14) Subjects having chipped teeth and defective restorations.
15) Subjects having deep periodontal pockets.
16) Subjects having bridgework in their teeth and dentures which interrupt during evaluation.
17) Subjects undergoing periodontal surgery within previous 6 months.
18) Subjects undergoing treatment with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs.
19) Subjects having uncontrolled metabolic disease.
20) Subjects overexposure to acidic by dietary and environment exposure.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the effectiveness of the test treatments by assessing change in plaque deposition, gingivitis, plaque induced gingivitis, teeth whiteness from baseline to post-treatment usage, within each treatment group and between treatment groups.
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
Secondary Outcome
Outcome
TimePoints
1. To evaluate the effectiveness of test treatments by assessing change in dental erosion and abrasion evaluated using erosion resistance test and abrasion scoring by Dentist and dentist trained evaluator
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
2. To evaluate the effectiveness of test treatments by assessing change in teeth sensitivity assessed by techniques like air-blast, tactile method, cold thermal stimuli and 20% acid solution (lemon solution) by Dentist and dentist trained evaluator
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
3. To evaluate the effectiveness of test treatments by assessing change in freshness evaluated using Tanita
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
4. To evaluate the effectiveness of test treatments by assessing change in persistent extrinsic stains evaluated using VITA Easyshade® V and Lobene Stain Index by Dentist and dentist trained evaluator
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
5. To evaluate the effectiveness of test treatments by assessing change in dental tartar evaluated using simplified calculus index by dentist and dentist trained evaluator
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
6. To evaluate the effectiveness of test treatments by assessing change in dental carries evaluated using International Caries Detection and Assessment System (ICDAS) by dentist and dentist trained evaluator
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
7. To evaluate the effectiveness of test treatments by assessing relief in toothache evaluated using VAS scoring scale for pain
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days)
8. To evaluate the effectiveness of test treatments by assessing change in inflammatory markers – MMP-8 through laboratory parameter
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 180 (±2 Days)
To evaluate the effectiveness of test treatments by assessing change in subjective perception questionnaire through 5-point Likert scale
baseline on Day 01 (prior to treatment usage) to post treatment assessments on Day 01 at T1 mins, T30 mins, Day 30 (±2 Days), Day 90 (±2 Days), Day 180 (±2 Days) and telephonic subjective perception questionnaire from baseline on Day 60 (±2 Days), Day 120 (±2 Days), Day 150 (±2 Days)
Target Sample Size
Total Sample Size="70" Sample Size from India="70" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
02/09/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, double-blind, two-arm, prospective, interventional clinical Study designed to evaluate the clinical safety, efficacy, and in-use tolerability of Meswak toothpastes in healthy adult subjects. The study will assess key oral health outcomes, including oral malodour (halitosis), dental biofilm accumulation (plaque), gingival inflammation (gingivitis), root surface carious lesions (root caries), dentine hypersensitivity (sensitivity), dental calculus deposition (tartar), and gingival bleeding.
A total of 70 subjects (35 subjects per test treatment) including both male and non-pregnant, non-lactating females aged between 18-65 years (both inclusive) at the time of consent will be enrolled in the study. The study aims to complete evaluation of 60 subjects (30 subjects per test treatment) for the study.
The potential subjects will be screened as per inclusion and exclusion criteria after obtaining written informed consent from the subjects. Subjects will be contacted telephonically by the screening department of NovoBliss Research prior to the enrolment visit. Subjects will be instructed to use the supplemental toothpaste during the 21-day conditioning period preceding baseline assessments.
The study will include a total of 05 In-person visits and 4 telephonic follow up. The subjects will be instructed to visit the facility as per the below visits:
Visit 01 (Within 21 Days from Day 01) : Screening, ICD obtained
Conditioning Period (21 Days from Day 01): Post Screening
Visit 02 (Day 01): Enrolment, Baseline Evaluations, Treatment Usage, Post Treatment Usage Evaluations (T1 And T30 Mins)
Visit 03 (Day 30 ± 2 Days): Treatment Usage Period And Evaluations
Remote follow up (Day 60 ± 2 Days): Treatment Usage, Compliance Check And Telephonic Evaluations
Visit 04 (Day 90 ± 2 Days): Treatment Usage Period And Evaluations
Remote follow up (Day 120 ± 2 Days):Treatment Usage, Compliance Check And Telephonic Evaluations
Remote follow up (Day 150 ± 2 Days): Treatment Usage, Compliance Check And Telephonic Evaluations
Remote follow up (Day 179 ± 2 Days): Treatment Usage, Compliance Check And Telephonic Instructions
Visit 05 (Day 180 ± 2 Days): Treatment Usage Evaluations And End Of Study.