| CTRI Number |
CTRI/2025/07/091573 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to Evaluate the Effectiveness of Restosmile Dental Care in Adults with Dentinal Hypersensitivity. |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single-Arm Clinical Study to Evaluate the Effectiveness of a Restosmile Dental Care on Adult Participants with Dentinal Hypersensitivity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/024/25 Version 1.0 dated 04-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Tyagi |
| Designation |
Principal Investigator |
| Affiliation |
Bensups Hospital |
| Address |
Bensups Hospital ,Ground Floor, OPD Area Dwarka Sub City, Sector 12, Dwarka New Delhi, Delhi 110075
New Delhi
DELHI
110075
India |
| Phone |
08587039389 |
| Fax |
|
| Email |
sagartyagi005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Manoj Karwa |
| Designation |
Head Clinical Trial & Pharmacovigilance |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited, Plot No. 136, sector 05.IMT Manesar, Gurugram, Haryana 122050, India
Gurgaon
HARYANA
122050
India |
| Phone |
09313367656 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Purushotam |
| Designation |
Senior Clinical Research Associate |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited, Plot No. 136, sector 05.IMT Manesar, Gurugram, Haryana 122050, India
Gurgaon
HARYANA
122050
India |
| Phone |
8448573595 |
| Fax |
|
| Email |
purushotam@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Aurora Nutraceuticals Private Limited,F-1 4, Basement, Okhla Industrial Area Phase-I, New Delhi, Delhi, India, 110020 |
|
|
Primary Sponsor
|
| Name |
Aurora Nutraceuticals Private Limited |
| Address |
F-1 4, Basement, Okhla Industrial Area Phase-I, New Delhi, Delhi, India, 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar Tyagi |
Bensups Hospital |
Bensups Hospital ,Ground Floor, OPD Area Dwarka Sub-City, Sector 12, Dwarka New Delhi, Delhi-110075
South West
DELHI
110075
India
New Delhi
DELHI |
08587039389
sagartyagi005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy both male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Restosmile Dental Care |
A pea-sized amount of the restosmile dental care toothpaste twice daily for a minimum of two minutes per brushing session for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and non pregnant or non lactating females between 18 and 70 years of age.
2.Participants with a self reported history of dentinal hypersensitivity.
3.Presence of localized or generalized dentinal hypersensitivity.
4.At least one or two teeth exhibiting sensitivity in response to stimuli.
5.Demonstrate sensitivity to evaporative air stimulus (e.g., Schiff sensitivity score more
than or equal to 2).
6.Good general and oral health, with a minimum number of natural teeth (e.g., 20).
7.Willing and able to participate in the study, follow the protocol, and provide signed
informed consent. |
|
| ExclusionCriteria |
| Details |
1. Presence of conditions causing pain similar to DH, such as active dental caries, heavily
restored or fractured teeth, pulpitis, or extensive loss of periodontal attachment/alveolar
bone.
2. Participants with orthodontic or prosthetic appliances that interfere with evaluation.
3. Participants who have used desensitizing treatments (including toothpastes or
mouthwashes) or received professional desensitizing procedures within a specified periodprior to baseline (e.g., two weeks to six months).
4. Participants who have undergone vital teeth bleaching within a specified period prior to
screening (e.g., two weeks).
5. Participants taking medication that could affect pain perception (e.g., daily analgesics,
anti-inflammatory drugs) or antibiotics within a specified period.
6. Participants with a known history of hypersensitivity or allergy to ingredients in the
restosmile dental care toothpaste.
7. Participants who consume tobacco or alcohol.
8. Suspected inability or unwillingness to comply with study procedures.
9. Presence of oral processes or habits that keep dentinal tubules exposed, such as poor
plaque control, enamel wear, cervical erosion, or incorrect oral hygiene technique.
10. Diagnosis of specific diseases that cause gingival loss, such as necrotizing ulcerative
gingivitis (NUG), periodontitis, or herpetic gingivostomatitis.
11. Recent crown preparation that may expose dentinal tubules |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in dentinal hypersensitivity from baseline using objective and
subjective assessments.
1.1.Thermal Test (Air Blast): Change in Visual Analogue Scale (VAS) score (0
10 scale) and categorical Schiff sensitivity scale.
1.2.Tactile Test: Change in Visual Analogue Scale (VAS) score (0–10 scale)and force in grams (using a Yeaple probe). |
1.Screening, Day 07, Day 14.
2.Screening, Day07, Day 14.
3.Screening, Day07, Day 14.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Daily diary or questionnaire to record the frequency and severity of sensitivity
in daily activities.
2.Change in total DHEQ-15 score and scores within each of the five domains (daily functional restrictions, coping behaviours, personal identity, social impact,
and emotional impact).
3.Change in overall subjective rating of dentinal hypersensitivity of the entire
dentition on a 0-10 scale.
4.Participant feedback will be collected through a structured questionnaire at the end of study. |
1.Screening, Day 07, Day 14.
2.Screening, Day07, Day 14.
3.Screening, Day07, Day 14.
4.Day 14. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 Prospective, Open-Label, Single-Arm Clinical Study to Evaluate the Effectiveness of a Restosmile Dental Care on Adult Participants with Dentinal Hypersensitivity over 2 week period. A total 50 (both male & female participants) 18 to 70 years will be enrolled. The primary objective is to assess the change in dentinal hypersensitivity from baseline using objective and subjective assessments ( Thermal Test, Tactile Test, Visual Analogue Scale). Secondary objective is to assess change in oral health related quality of life using the dentine hypersensitive experience questionnaire, Monitoring the overall subjective sensitivity of entire dentition. The study includes 3 visits baselines, day 07, day 14 only. |