| CTRI Number |
CTRI/2023/12/060912 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Oral Care] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the effect of a test product (Toothpaste) on subjects with dentinal hypersensitivity. |
Scientific Title of Study
Modification(s)
|
Prospective, open label, two-group, comparative clinical study to evaluate the effectiveness of a test product (i.e., Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monofluorophosphate) on subjects with dentinal hypersensitivity. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| C3B03068; DRL-IND-GGI-037-DENT/2023; Ver:01, Dated 26Oct23 |
Protocol Number |
| C3B03068;DRL-IND-GGI-037-DENT/2023;Ver:02,Dated 02Apr24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17,
Sigma 1 Corporate House,
BH. Rajpath Club,
Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Sagar Katare |
| Designation |
Medical Cluster Head- CR |
| Affiliation |
Dr. Reddy’s Laboratories Ltd. |
| Address |
Dr. Reddy’s Laboratories Limited
8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana – 500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Sagar Katare |
| Designation |
Medical Cluster Head- CR |
| Affiliation |
Dr. Reddy’s Laboratories Ltd. |
| Address |
Dr. Reddy’s Laboratories Limited
8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana – 500034, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Dr Reddy’s Laboratories Ltd., Medical Affairs Department, 7-1-27, Ameerpet, Hyderabad, Telangana – 500016, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Reddys Laboratories Ltd. |
| Address |
7-1-27, Ameerpet,
Hyderabad, Telangana - 500016
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT |
8000085049
pjoshi@cliantha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with dental hypersensitivity and eroded/damaged enamel |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monoflorophosphate |
Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of 60 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Males and Non-pregnant (self-declared)/Non-Lactating female subjects of age 18 to 60 years (both inclusive) at the time of consent.
2) Subjects having good general health as determined by the Investigator based on medical history and vital signs.
3) Subjects with localized and generalized dentinal hypersensitivity (preferably with equal number of localized and generalized DH in each group)
4) Subjects with mild to moderate dental hypersensitivity (tested by thermal testing).
5) Subjects complaining of dentinal hypersensitivity following a cold stimulus such as ice cream, iced drink, or a rapid jet of cool air to a particular tooth or teeth.
6) Subjects with eroded/damaged enamel (Grade 2 – 3 as per Ordinal scale for severity of dental erosion).
7) Subjects who are willing to participate in the study and give a signed consent.
8) Subjects should be willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Pregnant or breastfeeding or planning pregnancy during the study period.
2) Subjects with orthodontic bands.
3) Subjects with partial removable dentures and fixed partial dentures.
4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
5) Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
6) Subjects with history of treatment for dentin hypersensitivity
7) Poor periodontal condition
8) Subject who has used antibiotics any time during the one month prior to start of the study.
9) Subjects who consume alcohol.
10) Subjects smoking cigarette or consume any other form of tobacco.
11) Participation in a similar clinical study within the previous 30 Days.
12) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
For Group 1
1.To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha and cold spray for absent, mild, moderate or severe response recorded by the dentist at
2.To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at
2.To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at |
baseline (30 mins before direct product application), 30 secs (+5 secs) after completion of brushing.
Day 15 (+ 02 days), Day 30 (+ 02 days) and Day 60 (+ 02 days) after 30 secs (+5 secs) of completion of brushing. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
For Group 1
To assess the effect of test product in terms of enamel protection by grading erosion using Ordinal scale for severity of dental erosion on buccal & lingual surfaces of maxillary anterior teeth |
baseline (30 mins before direct product application), Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after completion of brushing. |
For Group 1
To assess Subjective evaluation questionnaires on dental hypersensitivity.
To assess Subjective evaluation questionnaires regarding general oral hygiene & dental health |
baseline (30 mins before direct product application), Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after brushing.
Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after completion of brushing. |
For Group 2
To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha & cold spray for absent, mild, moderate or severe response recorded by the dentist at |
baseline (30 mins before direct brushing), 30 secs (plus 5 secs) after completion of brushing.
Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after 30 secs (plus 5 secs) of completion of brushing. |
For Group 2
To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at |
baseline (30 mins before direct brushing), 30 secs (plus 5 secs) after completion of brushing.
Day 15 (plus 02 days), Day 30 (plus 02 days) & Day 60 (plus 02 days) after 30 secs (plus 5 secs) of completion of brushing. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="2"
Days="1" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
Brief Summary
Modification(s)
|
This is a prospective, open label, two-group, comparative clinical study to evaluate the effectiveness of a test product (i.e., Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monofluorophosphate) on subjects with dentinal hypersensitivity.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo dental assessment and subjective assessment. Safety will be assessed throughout the study by monitoring adverse events.
Simultaneously, a small subgroup comparative analysis will also be performed to understand if the leave on technique provides a faster relief from Dentinal Hypersensitivity as compared to only brushing. |