| CTRI Number |
CTRI/2025/08/093643 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study on the Effectiveness of Diode Laser–Assisted Desensitizing Agents for Dentinal Hypersensitivity |
|
Scientific Title of Study
|
Evaluation of effectiveness of different desensitizing agents used in combination with diode laser on dentinal hypersensitivity : 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 |
Dr Vaishnavi Chidrawar |
| Designation |
Post graduate student |
| Affiliation |
SMBT IDSR |
| Address |
SMBT Institute of dental sciences and research. Department of conservative dentistry and endodontics Room no 201
Nashik
MAHARASHTRA
422403
India |
| Phone |
7249808047 |
| Fax |
|
| Email |
vaishnavichidrawar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Patel |
| Designation |
Professor and HOD |
| Affiliation |
SMBT IDSR |
| Address |
SMBT Institute of dental sciences and research. Department of conservative dentistry and endodontics Room no 201
Nashik
MAHARASHTRA
422403
India |
| Phone |
9370587666 |
| Fax |
|
| Email |
pawanpatel25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Chidrawar |
| Designation |
Post graduate student |
| Affiliation |
SMBT IDSR |
| Address |
SMBT Institute of dental sciences and research. Department of conservative dentistry and endodontics Room no 201
Nashik
MAHARASHTRA
422001
India |
| Phone |
7774916891 |
| Fax |
|
| Email |
vaishnavichidrawar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT IDSR, Nandi Hills, Dhamangaon, Nashik. Department of conservative dentistry and Endodontics Room No. 201
pin code: 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Chidrawar |
| Address |
SMBT IDSR, Nandi Hills, Dhamangaon. Department of conservative dentistry and Endodontics Room No. 201
pin code- 422403 |
| 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 Vaishnavi Chidrawar |
SMBT Institute of dental sciences and research |
SMBT IDSR, Nandi Hills, Dhamangaon.
Department of conservative dentistry and Endodontics Room No. 201
Nashik
MAHARASHTRA |
7774916891
vaishnavichidrawar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novamin (Calcium Sodium Phosphosilicate) with diode laser
|
Novamin agent will be mixed with distilled water, and the freshly prepared paste will be applied to the non-carious cervical lesion, followed by diode laser activation for 60 seconds.
|
| Comparator Agent |
Diode laser (wavelength 810 nm)
|
Non-carious cervical lesions will be treated with a diode laser in non contact mode for 60 sec.
|
| Intervention |
GC tooth mousse (10 percent casein phosphopeptide–amorphous calcium phosphate),with diode laser.
|
GC tooth mousse will be applied on noncarious cervical lesion followed by diode laser activation for 60 sec.
|
| Intervention |
Gluma 5 percent glutaraldehyde and 35 percent HEMA (2 hydroxyethyl methacrylate) with Diode laser.
|
Gluma desensitizing agent will be applied on non carious cervical lesion and air dried for 20 sec followed by diode laser activation 60 sec.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Non carious cervical lesion Score 1(Depth less than 1 mm) or 2 (Depth 1 mm)according to Smith and Knight Tooth wear index
|
|
| ExclusionCriteria |
| Details |
Association with periodontal pockets or gingival recession;
Presence of carious lesions or restoration;
Evidence of cracks;
Primary teeth,
Presence of subgingival NCCLs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The combination of diode laser with desensitizing agents is expected to significantly reduce dentinal hypersensitivity, with some agents showing greater efficacy than others.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The adjunctive use of a diode laser with desensitizing agents is anticipated to provide a significant long-term reduction in dentinal hypersensitivity, with certain agents demonstrating superior and more sustained efficacy over time. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/08/2025 |
| 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="0"
Months="6"
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
|
Background-
Dentin hypersensitivity (DH)
is a common and painful condition encountered in dental practice, which can
greatly impact an individual’s quality of life by altering their dietary habits
and oral hygiene practices. Numerous topically applied desensitizers with
different modes of action are used in DH management. However, no consensus has
been reached on the ideal treatment
Aim- To
compare and evaluate effectiveness of Novamin, GC tooth mousse and Gluma
desensitizing agent used in combination with diode laser on dentinal
hypersensitivity.
Materials
and methods- 72
teeth with non carious cervical lesion (NCCLs) complaining of dentinal
hypersensitivity will be selected. 72 NCCLs will be randomly
distributed into 4 groups (Group A -Diode laser Group B- Novamin with Diode
laser, Group C- GC Tooth mousse with diode laser, Group D- Gluma with diode
laser) will be assigned different treatment protocol. Before initiating the treatment,
patient response of each NCCLs will be checked using Evaporative air test (EAT) and Schiff scale
(t0). In Group A Diode laser will be used alone In group B, C and D
desensitizing agent will be applied and activated using diode laser for 60s.
After completion of treatment effectiveness of the different therapeutic
protocols will be evaluated by recording
the patient response for each NCCL
following the EAT stimulus and the Schiff scale immediately at the end
of the treatment (t1) and after 1 week (t2), 1 month(t3), 3 month (t4), 6
month(t5) Statistical analysis will be done using Shapiro – Wilk test and ANOVA
test.
|