A study to assess the safety and effectiveness of toothpaste in human subjects with diabetes

Active, not recruiting

• Conditions: Diabetes mellitus due to underlying condition without complications, (2) ICD-10 Condition: K056||Periodontal disease, unspecified,

• Registration Number: CTRI/2023/09/057700
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

This is an open label,single arm, multicentric clinical study to evaluate the efficacy of testproduct in individuals with diabetes.

**Enrollment**: Following provision of informed consent and completion of allscreening assessments, eligible subjects will receive the test product. Atotal of 50 subjects to be enrolled with a minimum of 40 subjects expectedto complete the study.

**Test product usage**: Before the start of the study all subjects will be given instructionsfor oral hygiene, and usage of the products, brushing time and technique.Subjects will be instructed to brush their teeth twice daily, in morning beforebreakfast and at night just before sleeping. All subjects will be asked toavoid eating/drinking food for 30 minutes before the clinical evaluations. Allsubjects will be asked to clean the mouth thoroughly with fresh water beforeclinical evaluation.

**Duration**: The study duration is 12 weeks, during which, the subjects will beinstructed to brush their teeth twice daily with the test product. The subjectswill undergo safety and efficacy assessments at Day 1, Day 30+2, Day 60+2and Day 90+2.

**Study endpoints:**

Efficacy End points:

The efficacy of testproduct assessed by the difference between mean scores of Investigatorassessment scales from baseline to EOS:

Russell’s Periodontal Index

Loe & Silness Gingivalindex

Loe & Silness Plaqueindex

Odor analysis byOrganoleptic scale

Oral hydration analysis bySchimer’s test

Safety End Point:

The safety of test productassessed by the following:

Non worsening of BuccalIrritation Scoring from baseline to EOS

Adverse events(AE): AEs will be continuouslymonitored. All AEs will be followed until resolution or deemed stable or untilthe event is found to be due to another known cause (concurrent condition or medication)and clinical judgment indicates that further evaluation is not warranted.Should an Investigator be made aware of any serious AE (SAE) occurring any timeafter the active reporting period, the SAE (in case of reasonable causality)will be reported to Sponsor within 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-29
• Last Update Posted: 2023-12-16

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects with history of diabetes with HbA1c 6.5 to 10% (as determined by HbA1c report not more than 1 month old) 2.
• Subjects currently under standard of care for diabetes control.
• Subjects with age group 25 to 60 years 4.
• Subjects with mild to moderate periodontal complications as determined by Russell’s Periodontal Index 5.
• Subjects having at least 20 natural teeth 6.
• Willing to sign informed consent document and abide by the study procedures.

Exclusion Criteria

• Subject with history of Periodontal treatment performed within last 6 months of study onset 2.
• Subjects with intrinsic dental stains like smokers, tobacco chewers, etc 3.
• Subjects with known history of hypersensitivity to any test product 4.
• Pregnant and lactating subjects (female with child-bearing potential enrolled after Negative Urine Pregnancy test and advised suitable contraceptive method) 5.
• Subjects with active infectious diseases or poor immunity (like known case of hepatitis, human immunodeficiency virus, tuberculosis) as determined by the investigator 6.
• Subjects using any other technique to clean teeth (including tobacco, plant sticks etc) apart from toothpaste and brushing 7.
• Subjects with poor oral hygiene or poor oral condition which may interfere with the study results as determined by the investigator 8.
• Subjects with known bleeding disorders or vitamin C deficiency 9.
• Subjects with previous oral surgery or permanent dental malformations (like oral cyst, tumors, etc) 10.
• Subjects with recent history (within 3 months) of dental prosthetic appliances (like partial dentures) 12.
• Subject with clinically significant medical or oral conditions (like serious diabetic macrovascular diseases, severely deranged kidney or liver functions, vasculitis) that might interfere with the outcome of the study as determined by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. In supporting periodontal health by using Russell’s periodontal index.	Day 1, Day 30, Day 60 and Day 90.
2. In improving hydration in oral cavity by using Schirmer test	Day 1, Day 30, Day 60 and Day 90.
3. In reducing plaque buildup as evaluated by Loe & Silness Plaque index.	Day 1, Day 30, Day 60 and Day 90.
4. In reducing gum inflammation using Loe & Silness Gingival index.	Day 1, Day 30, Day 60 and Day 90.
5. In reducing mouth odor, providing mouth freshness, giving clean & healthy mouth feel by using Organoleptic scale.	Day 1, Day 30, Day 60 and Day 90.

Secondary Outcome Measures

Name	Time	Method
In suitability to provide comprehensive oral care in individuals with diabetes through Subjective self-assessment questionnaire	Day 1, Day 30, Day 60 and Day 90.

Trial Locations

Locations (2)

Dr.Yogesh Shahs Dental clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Vraj Dental Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Dr.Yogesh Shahs Dental clinic

🇮🇳Ahmadabad, GUJARAT, India

Dr Jahanvi Chavda

Principal investigator

07948983895

drjahanvichavda@gmail.com