| CTRI Number |
CTRI/2025/12/099027 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing tooth whitening and sensitivity with and without laser |
|
Scientific Title of Study
|
COMPARISON OF LASER ASSISTED AND CONVENTIONAL BLEACHING TECHNIQUES ON TOOTH COLOR CHANGE AND POST OPERATIVE SENSITIVITY- AN IN VIVO 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 |
Fathima Riya Shareef |
| Designation |
POST GRADUATE MDS |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Karnataka Kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
9895266999 |
| Fax |
|
| Email |
riyushareef@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Fathima Riya Shareef |
| Designation |
POST GRADUATE MDS |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Karnataka Kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
9895266999 |
| Fax |
|
| Email |
riyushareef@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M C Ponappa |
| Designation |
Professor |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Karnataka Kodagu
Kodagu
KARNATAKA
571218
India |
| Phone |
9591231400 |
| Fax |
|
| Email |
ponappamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Karnataka Kodagu |
|
|
Primary Sponsor
|
| Name |
Fathima Riya Shareef |
| Address |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Karnataka Kodagu |
| 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 |
| Fathima Riya Shareef |
Coorg institute of dental sciences |
Coorg institute of dental sciences Department of conservative dentistry and endodontics Room 7 K K campus Maggula Virajpet Kodagu Karnataka
Kodagu
KARNATAKA |
9895266999
riyushareef@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION REVIEW BOARD, COORG INSTITUTE OF DENTAL SCIENCES |
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 |
| Comparator Agent |
35% hydrogen peroxide gel |
applying 35% hydrogen peroxide gel on labial surface of teeth for a time period of 8 minutes followed by removal of gel by gauze and evaluating tooth color change. Above mentioned procedure will be repeated one more for each patient. |
| Intervention |
35% hydrogen peroxide gel activated by laser |
applying 35% hydrogen peroxide gel on labial surface of the teeth followed by laser (980nm) activation of 60 sec per tooth with low level laser tip on the tooth followed by removal of gel by gauze and evaluating tooth color change. Above mentioned procedure will be repeated once more for each patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patients with good health in the age group of 18 to 55 years presenting with discoloured upper or lower anterior teeth |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Patients with allergy to bleaching gel
Patients with generalised dental caries
Patients with hypersensitivity
Patients with fractured teeth
Non vital anterior teeth
Patients with generalised attrition and erosion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of Laser assisted and conventional bleaching on tooth color change and post operative sensitivity. |
To evaluate and compare the efficacy of Laser assisted and conventional bleaching on tooth color change and post operative sensitivity at the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intergroup comparison of the effects of laser assisted and conventional bleaching. |
compare the effects of bleaching in males & females at baseline. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="0"
Months="8"
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 is designed to be a split mouth study where 15 patients of both gender with discolored upper or lower anterior teeth will be enrolled. The total sample size calculated is 15 patients. This will be a split mouth study where the oral cavity is divided to right and left quadrant. One quadrant will be treated by conventional bleaching gel and the counterpart quadrant with bleaching gel activated by laser. Clinical photographs will be taken pre-operatively and post operatively to assess the tooth color change. Post operative sensitivity will be measured in each quadrant using VAS scale. Therefore this study aims to evaluate and compare the effectiveness of laser assisted and conventional bleaching on tooth color change and post operative sensitivity. |