| CTRI Number |
CTRI/2025/07/090536 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study between treatment outcomes of diode laser of wavelength 940nm and desensitizing solution containing 5% potassium nitrate for hypersensitive teeth-A split mouth randomized clinical study. |
|
Scientific Title of Study
|
Comparative evaluation of treatment
outcomes using diode laser of wavelength
940nm and desensitizing solution containing
5% potassium nitrate for dentinal hypersensitivity- A split mouth randomized 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 |
ANAM DILAAWEZ |
| Designation |
JUNIOR RESIDENT DOCTOR |
| Affiliation |
SCHOOL OF DENTAL SCIENCES ,SHARDA UNIVERSITY |
| Address |
928, Tower 8, Purvanchal Royal City, Sector Chi 5,Gautam Buddha Nagar, Uttar Pradesh.
School of dental sciences.Sharda university,Khowledge Park 3,Gautam Buddha Nagar,Uttar Pradesh.Pincode-201310.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
08755768988 |
| Fax |
|
| Email |
abdulanam694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANAM DILAAWEZ |
| Designation |
JUNIOR RESIDENT DOCTOR |
| Affiliation |
SCHOOL OF DENTAL SCIENCES ,SHARDA UNIVERSITY |
| Address |
928,TOWER 8,PURVANCHAL ROYAL CITY,SECTOR CHI 5,GREATER NOIDA,UTTAR PRADESH
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,SCHOOL OF DENTAL SCIENCES ,SHARDA UNIVERSITY,KNOWLEDGE PARK 3,GREATER NOIDA,UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
08755768988 |
| Fax |
|
| Email |
abdulanam694@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANAM DILAAWEZ |
| Designation |
JUNIOR RESIDENT DOCTOR |
| Affiliation |
SCHOOL OF DENTAL SCIENCES ,SHARDA UNIVERSITY |
| Address |
928,Tower 8,Purvanchal Royal City,Sector Chi 5,Gautam Buddha Nagar,Uttar Pradesh
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,School of Dental Sciences,Sharda University,Knowledge Park 3,Gautam Buddha Nagar,Uttar Pradesh, Pincode- 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
08755768988 |
| Fax |
|
| Email |
abdulanam694@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANAM DILAAWEZ |
| Address |
SCHOOL OF DENTAL SCIENCES, SHARDA UNIVERSITY, GREATER NOIDA, PINCODE- 201310 |
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE] |
|
|
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 |
| ANAM DILAAWEZ |
SCHOOL OF DENTAL SCIENCES ,SHARDA UNIVERSITY |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,SHARDA SCHOOL OF DENTAL SCIENCES, GREATER NOIDA, GAUTAM BUDHHA NAGAR, UTTAR PRADESH, 201310
Gautam Buddha Nagar
UTTAR PRADESH |
8755768988
abdulanam694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode laser |
Diode laser 980nm in wavelength for treating dentinal hypersensitivity. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient should have minimum one tooth in opposite quadrant with dentinal hypersensitivity without cavitation scored greater than 1 on Schiff scale
|
|
| ExclusionCriteria |
| Details |
1.Irreversible pulpitis or necrosis
2.Carious lesion
3.Active periodontal lesion
4.Defective restorations
5.Patient on medications under sedatives, analgesics and tranquilizers, anti-convulsants and anti- inflammatory medications.
6.Patient who has undergone professional hypersensitivity treatment within last 3 months or taking any over the counter treatment.
|
|
|
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.Tooth affected with dentinal hypersensitivity is irradiated and treated by diode laser of wavelength 980nm.
2.Hypersensitive tooth is desensitized using 5% potassium nitrate gel. |
1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of the treatment results after
treating a hypersensitive tooth with diode laser of 940nm and
5% potassium nitrate solution.
|
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
05/03/2026 |
| 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)
|
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
|
The purpose of this study is to evaluate and compare the treatment outcomes with diode laser of wavelength 940nm and 5% potassium nitrate desensitizing solution for dentinal hypersensitivity. The sample size will be divided into three groups (n=20 for each group) and will be selected randomly by lottery method. Group A will be treated with laser, group B will be treated with desensitizing solution and group C will receive both. Pre-operative pain assessment will be done. Syringe with air will be placed at a distance of 1cm perpendicularly from the concerned area of the tooth. A jet of air will be applied for 2secs. Patient’s response will be checked with Schiff’s scale. After pain evaluation, the concerned tooth is ultrasonically treated to remove any plaque and tartar. Group A is irradiated with diode laser of 940nm wavelength,1W power, in continuous, non-contact, wave mode for 20secs. Group B is treated with one droplet of the solution (containing 5%potassium nitrate) is placed and rubbed by an applicator tip and left for 5mins on the concerned area of the tooth. Group C is treated with first desensitizing solution, then the concerned tooth is laser irradiated. The measurements of the pain will be performed immediately postoperative, 1 and 3 months after treatment. Schiff scale will be used to quantify pain severity. |