| CTRI Number |
CTRI/2024/06/068300 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of Biomin Containing Toothpaste In The Management of Dental Hypersensitivity |
|
Scientific Title of Study
|
A Multicentric Observational Single Arm Study To Evaluate The Effectiveness Of Toothpaste Containing Fluoro Calcium Phosphosilicate (Biomin) In The Long-Term Relief Of Dentine Hypersensitivity |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Mishra |
| Designation |
Investigator |
| Affiliation |
Shataayu Dental Clinic |
| Address |
Shataayu Dental Clinic
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
Room No 1
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
9229585073 |
| Fax |
|
| Email |
dramitluvsu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mishra |
| Designation |
Investigator |
| Affiliation |
Shataayu Dental Clinic |
| Address |
Shataayu Dental Clinic
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
Room No 1
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
MADHYA PRADESH
452001
India |
| Phone |
9229585073 |
| Fax |
|
| Email |
dramitluvsu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mishra |
| Designation |
Investigator |
| Affiliation |
Shataayu Dental Clinic |
| Address |
Shataayu Dental Clinic
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
Room No 1
Scheme no. 103 Plot No 76
Kesar Bagh Road,
Indore Madhya Pradesh 452001
MADHYA PRADESH
452001
India |
| Phone |
9229585073 |
| Fax |
|
| Email |
dramitluvsu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Dr Amit Mishra |
| Address |
Shataayu Dental Clinic
Scheme no. 103, Plot No. 76,
Kesar Bagh Road,
Indore, Madhya Pradesh 452001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varun Suryawanshi |
Dr Suryawanshis Dental Care & Implant Centre & Polyclinic |
39, Sukhshanti Nagar, opp. Oriental Bank of Commerce,
Bicholi Hapsi Main Rd,
Indore - 452016, Madhya Pradesh
Indore
MADHYA PRADESH |
9082552095
varun.suryawanshi@gmail.com |
| Dr Amit Mishra |
Shataayu Dental Clinic |
Scheme no 103 Plot No 76
Kesar Bagh Road
Indore Madhya Pradesh 452001
Indore
MADHYA PRADESH |
9229585073
dramitluvsu@gmail.com |
| Dr Rakesh Thaper |
Thaper Dental Clinic |
1, Navjeevan Chamber, Vinobha Marg, Panch Batti, C Scheme, Ashok Nagar, Jaipur
Jaipur
RAJASTHAN |
9829015788
thaper@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Integrity Ethics Committee |
Approved |
| Integrity Ethics Committee |
Approved |
| SoMex Research And Health Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Toothpaste Containing Fluoro
Calcium Phosphosilicate
(Biomin) |
At the baseline, (Day 0) patients
with dentine hypersensitivity will
continue treatment with
fluoro-calcium phosphosilicate
containing toothpaste, to be
used twice daily, as per the
discretion of the investigator, for
a period of 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either sex in the age group of 18 to 70 years.
2. Patients with a self-reported history of dentinal hypersensitivity and prescribed toothpaste containing fluorocalcium phosphosilicate by the Investigator.
3. No clinically significant or relevant abnormalities in medical history or upon oral examination, or condition that would impact the participants safety, wellbeing, or the outcome of the study.
4. Good general oral health, with a minimum of 20 natural teeth.
5. Any 2 or more teeth with signs of sensitivity measured by a qualifying evaporative air assessment (Schiff sensitivity score greater than or equal to 2)
6.Patients willing to participate in the study and sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Individuals either with active dental caries, heavily restored, or cracked teeth, or with orthodontic or prosthetic appliances, or with localized or generalized gingivitis or pulpitis and heavy calculus or using any desensitizing toothpaste or mouthwash or any other desensitizing products up to two weeks before the start of the study.
2. Patients who have undergone vital teeth bleaching within two weeks, before the screening date.
3. Pregnant and nursing women.
4. Women with childbearing potential not practicing a reliable method of birth control.
5. Patients with a known history of hypersensitivity to ingredients of investigational product.
6. Suspected inability or unwillingness to comply with study procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste at Week 6. |
Day 0 and Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste from baseline to Weeks 4, 8, 16, and 24.
2. To monitor the oral health-related quality of life (QOL) as measured by the Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15) post-treatment with fluoro-calcium phosphosilicate toothpaste.
3. To analyze time to meaningful dentin pain relief on the VAS scale from baseline to Weeks 4, 8, 16, and 24 post-treatment with fluoro-calcium phosphosilicate toothpaste.
4. To monitor gingival health and supra-gingival plaque levels at baseline, and Weeks 12 and 24.
|
Weeks 4, 8, 12, 16, and 24 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="121" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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 - NO
|
|
Brief Summary
|
This is
a prospective, multicenter,
single-arm, open-label, investigator-initiated study designed to
assess the effectiveness and safety of fluoro-calcium phosphosilicate
containing toothpaste in the management of dentine hypersensitivity. The study population will include out-patients of
both sexes, with dentin hypersensitivity visiting the dental clinics, Shataayu
Dental Clinic, Scheme no. 103, Plot No. 76, Kesar Bagh Road, Indore, Madhya
Pradesh, India, or Thaper Dental Clinic 1, Navjeevan Chamber, Vinobha Marg,
Panch Batti, C Scheme, Ashok Nagar, Jaipur, Rajasthan India; and are clinically
indicated for the treatment with toothpaste containing fluoro-calcium
phosphosilicate, as per the discretion of the investigator. It is expected that
approximately 120 patients with dentin hypersensitivity will be enrolled in the
study. At baseline (Visit 1 [Day 0]), patients with dentine hypersensitivity will be evaluated for cold
stimulus scores, assessed by the Schiff Cold Air
Sensitivity Scale (SCASS) score, the subjective impact of dentine
hypersensitivity on the patient’s quality of life (QoL) life by 15 items Dentine
Hypersensitivity Experience Questionnaire (DHEQ-15) score and participants’
pain score on a 10-point visual analog scale (VAS). The patient will continue
receiving the investigational product Hydent Pro toothpaste for the period of
24 weeks, as per the discretion of the investigator and according to the study
protocol. Progress made by the patient will be reviewed in
clinical on Weeks 4,6,8,12,16, and 24. |