| CTRI Number |
CTRI/2026/02/104998 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating bleaching effectiveness of opalescence Endo product for discolored teeth |
|
Scientific Title of Study
|
Internal Bleaching: Evaluation of the Effectiveness of Opalescence Endo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lisha Alphonsa A |
| Designation |
Postgraduate student |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6,
Department of Conservative Dentistry and Endodontics,
CSI college of Dental sciences and Research,
129, East veli Street,
Madurai-625001
Madurai
TAMIL NADU
625001
India |
| Phone |
9043218599 |
| Fax |
|
| Email |
lishaalphonsaarockiam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6,
Department of Conservative Dentistry and Endodontics,
CSI college of Dental sciences and Research,
129, East veli Street,
Madurai-625001
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room no. 6,
Department of Conservative Dentistry and Endodontics,
CSI college of Dental sciences and Research,
129, East veli Street,
Madurai-625001
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Lisha Alphonsa A |
| Address |
Room no.6,
Department of Conservative Dentistry and Endodontics,
CSI College of Dental Sciences and Research,
129, East Veli Street,
Madurai-625001 |
| 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 Lisha Alphonsa A |
CSI College of Dental Sciences and Research |
Room no. 6,
Department of Conservative Dentistry and Endodontics,
CSI college of Dental sciences and Research,
129, East veli Street,
Madurai-625001.
Madurai
TAMIL NADU |
9043218599
lishaalphonsaarockiam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Opalescence endo |
Composition:35% Hydrogen peroxide
Company name: Ultradent products
Manufacturing country: USA
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Caries-free anterior teeth without restoration on labial surface
Absence of tooth sensitivity
Anterior teeth determined to be A2 shaded or darker
Duration of injury-Few months to years
Patients who could read and sign the consent form and are willing to attend the follow-up visits |
|
| ExclusionCriteria |
| Details |
Patients with dentinal sensitivity
Patients who had undergone tooth whitening procedures previously
Teeth with tetracycline stains or fluorosis
Patients having habits such as smoking, pan chewing or parafunctional habits
Patients who had non carious cervical lesions
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of opalescence |
3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess color stability and Patient satisfaction |
3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study aimed to evaluate the effectiveness of Opalescence Endo (35% hydrogen peroxide) in discolored non-vital anterior teeth using internal bleaching technique. |