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CTRI Number  CTRI/2024/05/068009 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   A clinical endpoint study to assess the effect of dental cream, strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy male subjects. 
Scientific Title of Study   A prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
012-CL-2024 Version 02 Date 04/04/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Srikanth 
Designation  Assistant Manager 
Affiliation  AnaCipher Clinical Research Organisation 
Address  Mirra Kamshetty Mall 2nd, 3rd and 4th Floor Ramanthapur, Medchal - Malkajgiri District, Hyderabad-500 013, Telangana, India

Medchal
TELANGANA
500013
India 
Phone  9133278073  
Fax    
Email  srikanth.n@anacipher.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Srikanth 
Designation  Assistant Manager 
Affiliation  AnaCipher Clinical Research Organisation 
Address  Mirra Kamshetty Mall 2nd, 3rd and 4th Floor Ramanthapur, Medchal - Malkajgiri District, Hyderabad-500 013, Telangana, India

Medchal
TELANGANA
500013
India 
Phone  9133278073  
Fax    
Email  srikanth.n@anacipher.com  
 
Details of Contact Person
Public Query  
Name  Mr Chirag Khatri 
Designation  Head Operations 
Affiliation  AnaCipher Clinical Research Organisation 
Address  Mirra Kamshetty Mall 2nd, 3rd and 4th Floor Ramanthapur, Medchal - Malkajgiri District, Hyderabad-500 013, Telangana, India

Medchal
TELANGANA
500013
India 
Phone  9908392000  
Fax    
Email  chirag.khatri@anacipher.com  
 
Source of Monetary or Material Support  
Indoco Remedies Limited R-92-93, T.T.C Industrial Area Thane Belapur Road, Rabale MIDC Navi Mumbai – 400701 Tel No.: (91-22) 2769 9900 Fax No.: (91-22) 2769 5500  
 
Primary Sponsor  
Name  Indoco Remedies Limited 
Address  R-92-93, T.T.C Industrial Area Thane Belapur Road, Rabale MIDC Navi Mumbai – 400701 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Srikanth  AnaCipher Clinical Research Organisation  Mirra Kamshetty Mall, 2nd, 3rd and 4th Floor, Clinical Department, Clinical pharmacology unit, Ramanthapur, Medchal - Malkajgiri District, Hyderabad-500 013, Telangana, India
Medchal
TELANGANA 		 9133278073

srikanth.n@anacipher.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vasavi Medical & Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human male volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SENSOFORM® (Strontium Chloride 10% w/w Medicated Dental Cream)  1.5 ± 0.2gm of tooth paste for 2min brushing as external application but not for consumption. Total duration of the intervention is 60 minutes for blood glucose monitoring and 180 minutes for saliva PH monitoring.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  1. Healthy human male subjects within the age range of 18 to 55 years (inclusive of both)
2. Body-mass index of more than or equal to 18.5 kg/m2 and less than or equal to 30.0 kg/m2, with body weight not less than 50 kg.
3. Willingness to provide written informed consent to participate in the study.
4. Absence of significant disease, laboratory examinations within acceptable range, medical history and with normal physical examination during the screening.
5. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol. 
 
ExclusionCriteria 
Details  1. Personal / family history or presence of allergy or hypersensitivity to Strontium Chloride or to any of the components of the formulations.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Presence of tooth sensitivity
4. Difficulty in brushing due to tooth decay
5. History of donation of blood (one unit) within 3 months prior to study check-in or difficulty in donating blood.
6. Participation in a drug research study within past 3 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in blood glucose levels  Baseline (0.00) to 15, 30 and 60 minutes post application of toothpaste 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in salivary pH  Baseline (0.00) to 15, 30, 60, 120 and 180 minutes post application of toothpaste. 
To examine the subject’s acceptance by assessing palatability questionnaire  Within 15 minutes of post brushing 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2024 
Date of Study Completion (India) 05/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  This is for internal evaluation only.

  2. What additional supporting information will be shared?
    Response - None of the above
    Response (Others) -  This is for internal evaluation only.
  3. Who will be able to view these files?
    Response (Others) -  This is for internal evaluation only.

  4. For what types of analyses will this data be available?
    Response (Others) -  This is for internal evaluation only.

  5. By what mechanism will data be made available?
    Response (Others) -  query related to trial data can be asked through email - chirag.khatri@anacipher.com

  6. For how long will this data be available start date provided 15-06-2024 and end date provided 30-06-2024?
    Response (Others) -  for 15 days after completion of trial

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This study is a prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions.

Healthy adult human subjects of 18 to 55 years (both inclusive) were recruited. Body-mass index of ³ 18.5 kg/m2 and £ 30.0 kg/m2, with body weight not less than 50 kg who were judged healthy on the basis of a pre-study physical examination and clinical laboratory tests were included in the study.

Changes in blood glucose levels from baseline (0.00) to 15, 30 and 60 minutes and salivary pH from baseline (0.00) to 15, 30, 60, 120 and 180 minutes post application of toothpaste was evaluated using repeated measures ANOVA.

Subject’s acceptance on dental toothpaste by assessing palatability questionnaire was evaluated using Wilcoxon non-parametric test.

Based on graphical representation, strontium Chloride 10 % Medicated Dental Cream does not increase blood glucose levels at various time points i.e.; 15, 30 and 60 minutes. Strontium Chloride 10 % Medicated Dental Cream dose not caused significant change in salivary pH; it maintained within the range of 6.96 to 7.12. Normal pH range of saliva is 6.7-7.3.
62 % subjects reported ‘good’ & 28 % subject reported ‘very good’ on taste.

There were no reports of death, serious or unexpected adverse events. A total of 02 adverse events were reported in two (02) subjects during entire conduct of the study. No adverse events were reported during study period. During post study safety assessment, two (02) adverse events were reported in 02 participants. In that, Increased glucose random was reported in two participants (i.e. Participant IDs: 10 & 33) which was mild in severity and possibly related to the dental cream application. All the adverse events were considered as resolved with no sequelae (except Participant ID: 10 was considered as lost to follow-up).

Based on results, it has been concluded that the Strontium Chloride 10% w/w Medicated Dental Cream does not increase blood glucose levels at various time points i.e.; 15, 30 and 60 minutes in healthy, adult, human male subjects, under fasting conditions.
Strontium Chloride 10% w/w Medicated Dental Cream does not cause significant change in salivary pH; it maintained within the range of 6.96 to 7.12. Almost 62 % subjects reported ‘good’ & 28 % subjects reported ‘very good’ on taste.
 
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