| CTRI Number |
CTRI/2025/11/098131 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing three teeth whitening products without peroxide that people commonly buy without a prescription. |
|
Scientific Title of Study
|
Comparative clinical evaluation of three different non-peroxide based teeth whitening agents in those seeking over the counter treatment - A randomised clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manalee Manish Mapara |
| Designation |
PG Student |
| Affiliation |
K M Shah dental college and hospital |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7383664845 |
| Fax |
|
| Email |
drmmapara23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Professor and head |
| Affiliation |
K M Shah dental college and hospital |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Professor and head |
| Affiliation |
K M Shah dental college and hospital |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M shah dental college and hospital, Sumandeep vidyapeeth University, Waghodia road, Vadodara, Gujarat, India Pincode-391760 |
|
|
Primary Sponsor
|
| Name |
Dr Manalee Mapara |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nimisha Shah |
K M Shah dental college and hospital |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT |
09998994299
nshah7873@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Charcoal based teeth whitening |
Charcoal based teeth whitening done using Smiloshine advance teeth whitening serum. Apply the agent and wait for 5 min then rinse. The same procedure will be repeated for 14 consecutive days once daily. |
| Comparator Agent |
PAP and HA based teeth whitening |
PAP and HA based teeth whitening done using Masofta teeth whitening gel. Leave the gel on teeth for about 30 minutes. Then rinse mouth thoroughly with water. The same procedure will be repeated for 14 consecutive days twice daily. |
| Intervention |
Papain and bromelaine based teeth whitening |
Papain and bromelaine based teeth whitening done using Perfora purple magic teeth whitening serum. Let it sit on the teeth for 60 seconds and rinse. The same procedure will be repeated for 14 consecutive days twice daily. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients (Category: American Society of Anaesthesiologists class 1 (ASA House of Delegates 2014)32 aged 18-35yr both male and female patients will be included in the study.
2. Patient having Good/general oral hygiene will be included.
3. Patients with chief complain of mild extrinsic discoloration or staining of teeth.
4. Patient with vital teeth giving normal positive response on cold and EPT testing will be included in the study.
5. Patients with no history of teeth sensitivity will be included.
6. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
7. Only those patients who are willing to take teeth whitening treatment will be included in this study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having habit of smoking or tobacco chewing will be excluded from study.
2. Patients having intrinsic staining of teeth will be excluded from study.
3. Patients having parafunctional habits will be excluded from study.
4. Patients undergoing orthodontic treatment will be excluded from study.
5. Patients having previous restoration on anterior teeth will be excluded from study.
6. Patients with previous use of teeth bleaching or teeth whitening agent will be excluded from study.
7. Patients having known allergies to any product ingredients will be excluded from study.
8. Pregnant and lactating patients will be excluded from study.
9. Patients having periodontitis and poor oral hygiene will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Help to identify and compare the effectiveness, onset of action, and safety profiles of different non-peroxide-based teeth whitening agents—specifically, PAP+HA-based, charcoal-based, and papain and bromelain enzyme-based formulations. It is expected to reveal which agent provides the most noticeable and rapid whitening effect with minimal side effects like sensitivity or irritation. |
After 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
28/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 randomized clinical study compared the effectiveness of three different non-peroxide teeth-whitening products (PAP & HA containing, charcoal-containing, and papain & bromelain containing teeth whitening agents) commonly purchased over the counter. Total 54 individuals seeking simple, at-home whitening solutions were randomly assigned to use one of the three products. Their tooth color was evaluated before and after the procedure to see how well each product worked and how long the results lasted. The study also monitored any sensitivity or side effects experienced by participants. Overall, the research helps identify which non-peroxide whitening agent provides the most noticeable and safest whitening results for everyday users. |