| CTRI Number |
CTRI/2025/11/097303 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Tooth Colour Change Following Laser and Conventional Bleaching in Root Canal–Treated Discoloured Teeth: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Evaluation of colour change following walking bleach with that of combined intra and extra coronal laser bleaching of endodontically treated discoloured teeth using Spectrophotometer and Vita Classical Shade Guide - A Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunima N |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department of conservative dentistry and endodontics ,Room NO 60 , Government Dental College Kozhikode, kerala
Kozhikode
KERALA
673008
India |
| Phone |
7592853222 |
| Fax |
|
| Email |
arunima.n1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasree S |
| Designation |
Head of the Department |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department of conservative dentistry and endodontics ,Room NO 60 , Government Dental College Kozhikode, kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasree S |
| Designation |
Head of the Department |
| Affiliation |
Government Dental College Kozhikode |
| Address |
Department of conservative dentistry and endodontics ,Room NO 60 , Government Dental College Kozhikode, kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447276940 |
| Fax |
|
| Email |
jsree21@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Government Dental College Kozhikode
Room no 60 4th floor,
kozhikode ,Kerala , pin 673008 |
|
|
Primary Sponsor
|
| Name |
Arunima N |
| Address |
Department of Conservative Dentistry And Endodontics Room No 60, Government Dental College Kozhikode , Kerala ,P.O 673008 |
| 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 Jayasree S |
Government Dental College Kozhikode |
Department of Conservative Dentistry and Endodontics,Room no 60, 4th floor,Government Dental College Kozhikode ,pin 673008
Kozhikode
KERALA |
9447276940
jsree21@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Dental College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients with discolored root canal treated upper anterior teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 conventional walking bleaching
|
The following parameters are assessed
1.Shade evaluation done before treatment .
2.Shade evaluation again done after 2 weeks
3.Shade evaluation done in after 1 month to check the colour regression. |
| Intervention |
Group 2 intra and extra coronal laser bleaching |
he following parameters are assessed
1.Shade evaluation done before treatment .
2.Shade evaluation again done immediately after the treatment .
3.Shade evaluation done after 1 month to check the colour regression |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 18 to 50 years.
2. Overall good health and oral condition.
3. Discoloured root canal-treated maxillary incisors and canines, with a 3-4 shade darker
than adjacent natural vital teeth on the Vita Classical Shade Guide.
4. Root canal treated anterior teeth with satisfactory obturation and no periapical lesions
evident in IOPAR
5. No previous bleaching treatment, no caries or restoration or periodontal diseases
6. Absence of crowns and bridges |
|
| ExclusionCriteria |
| Details |
1. Teeth with extensive restorations
2. Tooth discomfort.
3. Any systemic health disorders.
4. Pregnant or breastfeeding individuals.
5. Moderate to severe dental fluorosis or staining caused by tetracycline.
6. Active orthodontic treatment.
7. History of orofacial tumors or tooth abnormalities, hereditary defects. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Shade Evaluation : The colour of each tooth will be assesed following intra and extra coronal laser bleaching treatment and walking bleach technique |
1.Shade Evaluation assesed at baseline and immediately following intra and extra coronal laser bleaching treatment and in walking bleach technique at baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shade Regression Evaluation will be assesed in intra & extra coronal laser bleach group & walking bleach group
|
Shade Regression Evaluation assessed after 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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="2"
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
|
Evaluation of colour change following walking bleach with that of intra and extra coronal laser bleaching of endodontically treated discoloured teeth using spectrophotometer and vita classical shade guide - a randomised clinical trial The study evaluates the the effect of combined intra and extra coronal laser bleaching technique on the colour change of root canal treated discoloured maxillary anterior teeth and compare its efficacy with the conventional walking bleach technique. The sample size of the study is 30 and the study period is 18 months.
The null hypothesis states that Combined intra and extra coronal laser bleaching is not a better alternative for attainment of immediate colour change in root canal treated discoloured maxillary anterior teeth when compared to conventional walking bleach technique.
The outcome are assessed as follows Shade Evaluation: done on both group at baseline , that is before the treatment. In Group 1 Conventional walking bleach technique colour evaluation done after 2weeks . In Group 2 intra and extra coronal laser bleaching colour evaluation is done immediately. Colour regression in both groups evaluated after 1month.
|