FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079459 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Diode laser versus potassium oxalate gel for the treatment of dentinal hypersensitivity: A randomized controlled trial.  
Scientific Title of Study   Comparative evaluation of efficacy of diode laser with potassium oxalate gel for the treatment of subjects with dentinal hypersensitivity:A randomized controlled 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  Dr Sangeeta Muglikar 
Designation  MDS Periodontics 
Affiliation  YMT Dental college 
Address  Department of Periodontology and Implantology, Room no.3B, ground floor, Ymt Dental College,Yerela Medical, 18, Belpada Rd, Sector 4, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9322815805  
Fax    
Email  drmuglikar2006@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Muglikar 
Designation  MDS Periodontics 
Affiliation  YMT Dental college 
Address  Department of Periodontology and Implantology, Room no.3B, ground floor, Ymt Dental College,Yerela Medical, 18, Belpada Rd, Sector 4, Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9322815805  
Fax    
Email  drmuglikar2006@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sangeeta Muglikar 
Designation  MDS Periodontics 
Affiliation  YMT Dental college 
Address  Department of Periodontology and Implantology, Room no.3B, ground floor, Ymt Dental College,Yerela Medical, 18, Belpada Rd, Sector 4, Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9322815805  
Fax    
Email  drmuglikar2006@yahoo.co.in  
 
Source of Monetary or Material Support  
Prime Dental Products Pvt Ltd, Plot No 148, Rd Number 24, near Bhatia Glass, Wagle Industrial Estate, Thane West, Thane, Maharashtra 400604,India 
 
Primary Sponsor  
Name  Dr Dhruti Shah 
Address  Ymt Dental College,Girls Hostel,Yerela Medical, 18, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhruti Shah  Y.M.T Dental College and Hospital  Department of Periodontology and Implantology, Room no.3B, ground floor,18, Belpada Rd, Sector 4, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA 		 9322815805

dhrutishah98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Y.M.T Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diode laser  Diode LASER having 810 nm of wavelength,0.5 W of power in continuous wave mode. Each tooth will be irradiated for 90 seconds in noncontact mode  
Comparator Agent  Potassium oxalate gel  potassium oxalate gel with an applicator needle directly on the sensitive area for 90 seconds . 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i. Dentinal hypersensitivity with single rooted anterior teeth.
ii. Non-carious cervical lesion.
iii. Bilateral sites should be present.
iv. VAS scale of 4cm or above in both the sites. 
 
ExclusionCriteria 
Details  i. Subjects who have received any office care or home care treatment with desensitizing agents during the past 6 months.
ii. Subjects with a history of antibiotics, anti-inflammatory drug,
or immunosuppressive drug therapy in the past 6 months.
iii. Subjects who underwent periodontal treatment in the past 6
months.
iv. The teeth having carious lesions, extensive restorations,
endodontic treatment on the selected teeth.
v. Teeth diagnosed to have cracked tooth syndrome, vertical
fracture, or pulpitis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess pain using using Visual Analogue Scale after
i. Air blast Stimulus
ii. Cold Stimulus
 		 1 week,2 weeks, and 1 month of interval.
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Nil 
 
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 3 
Date of First Enrollment (India)   09/02/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhrutishah98@gmail.com].

  6. For how long will this data be available start date provided 19-01-2024 and end date provided 19-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study was conducted to compare the efficacy of Diode Laser and Potassium oxalate gel for the treatment of dentinal hypersensitivity in subjects between 20-60 years of age group at 1-week, 2 weeks, and 1-month intervals with respect to the Visual Analogue Scale using air blast stimulus and cold stimulus. The primary hypothesis of the study states that ’’There is a difference in efficacy of diode laser and potassium oxalate gel for the treatment of subjects with dentinal hypersensitivity of either sex between 20-60 years of age at 1 week,2 weeks and 1 month.’’ 
Close