A clinical study to check the safety and effectiveness of toothpaste
- Conditions
- Healthy adult volunteers
- Registration Number
- CTRI/2022/08/044960
- Lead Sponsor
- Himalaya wellness company
- Brief Summary
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|This is a prospective, open label, clinical study to evaluate the oral mucosal safety and efficacy of test product in healthy adult subjects.
A total of 40 subjects are expected to complete the study.
Following provision of informed consent and completion of all screening assessments, eligible subjects will receive the test product.
Before the start of the study all subjects will be given instructions for oral hygiene, and usage of the test product, brushing time and technique.
Subjects are instructed to use pea size amount of toothpaste, brush thoroughly and do not swallow. Toothpaste was used for brushing the teeth for 2 mins, twice a day (In the morning and before bedtime) for 45days. First use will be done at site, pre and post use of test product assessment will be done on day 1.
All subjects will be asked to avoid eating/drinking food for 30 minutes before the clinical evaluations.
***Clinical assessment:***
Each participating volunteer will complete a baseline dental examination on day 1 before use of test product and subjects will be asked to brush the teeth at site and assessment will be performed post use of test product.
The following clinical assessments will be carried out by the Investigator
The clinical efficacy assessment will be carried out through:
1. Silness and Loe plaque index
2. Loe and Silness Gingival Index
3. VITA Shade
4. Subjective self-administered questionnaire
Safety assessment:
1. Buccal irritation scoring as safety parameter
2. Adverse event reporting
**Plaque index:** The efficacy of test product in fighting plaque will be assessed by evaluating Silness and Loe plaque index (1965).
The plaque scores will be based on recording both soft debris and mineralized deposits on the teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) will be given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria:
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|**Scores**
**Criteria**
|0
No plaque
|1
A film of plaque adhering to the free gingival margin and
Adjacent area of the tooth. The plaque may be seen in situ only after
application of disclosing solution or by using the probe on the
tooth surface.
|2
Moderate accumulation of soft deposits within the gingival
pocket,or the tooth and gingival margin which can be seen
with the naked eye.
|3
Abundance of soft matter within the gingival pocket and/or
on the tooth and gingival margin.
**Gingival Index:** The efficacy of the test product in supporting healthy gums was evaluated by Loe and Silness Gingival Index scoring.
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| --- | --- |
|**Score**
**Condition**
|0
Absence of inflammation
|1
Mild inflammation; slight change in color and little
change in texture. No bleeding on probing
|2
Moderate inflammation; moderate glazing, redness,
Oedemaand hypertrophy; bleeding on sensing
|3
Severe inflammation; marked redness and oedema;
tendency to spontaneous bleeding; ulceration
|4
Permanent and primary tooth missing
**VITA shade assessment:** The efficacy of the test product variant in white teeth VITA Shade for evaluating whiter teeth:
The VITA classical A1 – D4 shade guide serves to accurately determine tooth shade. The arrangement of the shades in the VITA classical family of shades is as follows:
A1 - A4 (reddish-brownish)
B1 - B4 (reddish-yellowish)
C1 - C4 (greyish shades)
D2 - D4 (reddish-grey)
**Buccal irritation:** The scoring will be done as per the below described procedure.
The scoring will be performed through monitoring of the specific areas of oral cavity as per the Table below.
**Buccal Irritation Scoring**
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| --- | --- | --- | --- | --- |
|Areas of oral cavity
Irritation Grading
|0
1
2
3
|Buccal mucosa
|Labial mucosa
|Sublingual mucosa
|Mucobuccal fold
|Gingiva
|Tongue
|Hard and soft palate
The dental examiner will rate the irritation/inflammation on the soft tissues using below scale;
- 0=none (normal),
- 1=erythema plus slight edema (mild),
- 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate),
- 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).
The adverse events will be recorded thorough monitoring the hard tissue / soft tissue oral health and as reported by the subject.
**Subjective questionnaire evaluations**:
The efficacy of test product in Preventing mouth odour, providing of Mouthfreshness upto X hours, maintain clean and healthy mouth and providing freshbreath through subjective questionnaire.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- Subjects with age group 18 years to 60 years in general good health and oral health and are willing to provide consent to the study 2.
- Subjects with moderate oral hygiene and adhering to basic habits like using standard brush paste 3.
- No history of any clinically significant medical condition 4.
- Willing to abide by and comply with the study protocol 6.
- Available to comply the study procedure for the entire duration of the study.
- Should not have participated in a similar investigation in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study.
- 1.A known history or present condition of hypersensitivity to any test product 2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette 3.Pregnant and lactating subjects 4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month 5.
- Any history of periodontal therapy by surgical interventions 6.Any history of dentine hypersensitivity treatment 7.
- Any removable appliances such as a removable partial denture or orthodontic retainer 8.Having intrinsic dental stains 9.Having Chronic Generalized Periodontitis 10.
- Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index Baseline/ day 1 | Day 15 | Day 30 | Day 45 1.To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index Baseline/ day 1 | Day 15 | Day 30 | Day 45 3.To determine the teeth whitening effect of test product as evaluated by VITA shade card. Baseline/ day 1 | Day 15 | Day 30 | Day 45 4.To determine efficacy in Preventing mouth odour, providing of Mouth freshness upto X hours, maintain clean and healthy mouth and providing fresh breath through subjective self-administered questionnaire Baseline/ day 1 | Day 15 | Day 30 | Day 45
- Secondary Outcome Measures
Name Time Method To determine the safety of test product by buccal irritation score and subject reported adverse events. Baseline/ day 1
Trial Locations
- Locations (1)
Dental Care Centre
🇮🇳Bangalore, KARNATAKA, India
Dental Care Centre🇮🇳Bangalore, KARNATAKA, IndiaDr Vamsi Kalyan YPrincipal investigator9886300821yaragondavamsi@yahoo.co.in