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CTRI Number  CTRI/2024/05/068158 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Diode laser and Iontophoresis with 2% NaF in the management of Dentinal hypersensitivity 
Scientific Title of Study   Efficacy Comparison of the Diode Laser and Iontophoresis with 2% NaF in the management of 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 Disha Hirani 
Designation  PG student 
Affiliation  Hitkarini Dental College & Hospital, Jabalpur, Madhya Pradesh 
Address  Department of Conservative dentistry and Endodontics Room no- 6 Hitkarini Dental College and Hospital Hitkarini hills, Dumna airport road, Jabalpur, M.P. - 482001, INDIA

Jabalpur
MADHYA PRADESH
482001
India 
Phone  09406551006  
Fax    
Email  hiranidisha21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SP Mantri 
Designation  Head of Department 
Affiliation  Hitkarini Dental College & Hospital, Jabalpur, Madhya Pradesh 
Address  Department of Conservative Dentistry and Endodontics Room no- 6 Hitkarini Dental College and Hospital Hitkarini hills, Dumna airport road, Jabalpur, M.P. - 482001, INDIA

Jabalpur
MADHYA PRADESH
482001
India 
Phone  9425832314  
Fax    
Email  shivmantri24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Disha Hirani 
Designation  PG student 
Affiliation  Hitkarini Dental College & Hospital, Jabalpur, Madhya Pradesh 
Address  Department of Conservative dentistry and Endodontics Room no- 6 Hitkarini Dental College and Hospital Hitkarini hills, Dumna airport road, Jabalpur, M.P. - 482001, INDIA

Jabalpur
MADHYA PRADESH
482001
India 
Phone  09406551006  
Fax    
Email  hiranidisha21@gmail.com  
 
Source of Monetary or Material Support  
Hitkarini dental college and hospital, jabalpur 
 
Primary Sponsor  
Name  Dr Disha Hirani 
Address  Department of Conservative dentistry and Endodontics Room no- 6 Hitkarini Dental College and Hospital Hitkarini hills, Dumna airport road, Jabalpur, M.P. - 482001, INDIA  
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 Disha Hirani  Hitkarini Dental College and Hospital  Department of Conservative dentistry and Endodontics Room no- 6 Hitkarini hills, Dumna airport road, Jabalpur, M.P. - 482001, INDIA
Jabalpur
MADHYA PRADESH 		 09406551006

hiranidisha21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hitkarini Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diode laser  Biolase epicx diode laser Power- 1.5W pulsed (50% duty cycle) Diode laser will be applied perpendicular to the long axis of the tooth in a non-contact mode for 90 seconds, starting 5mm away from the tooth surface. Slow, circular motion will be used while moving the tip closer to tooth surface. If the patient feels discomfort, tip will be moved back to 5mm. On persisting hypersensitivity, power will be increased to 1.80W and 30/30ms for 90 seconds. 
Comparator Agent  IONTOPHORESIS with 2% NaF Gel  IONTOPHORESIS UNIT- (JONOFLUOR SCIENTIFIC®, MEDICAL) A sponge with thin layer of 2% NaF gel will be placed on autoclaved tray lined by conducting metal strip which will be kept in contact with affected teeth surfaces. The current will be maintained at 2-3 mA for 2–3 min. This will be repeated three times during single appointment at an interval of 2 min between each application 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) An age limit between 20 and 50 years, irrespective of the gender.
2) Patients having sensitive permanent teeth surfaces [buccal/facial aspects of incisors, canines, or premolars] with wasting diseases and/or gingival recession having sensitivity to air blast/ visual analog scale score (VAS) ≥ 3 and ≤6.
3) No history of periodontal therapy in the previous 3 months.
4) Good systemic health of the selected patients with clinically elicitable DH.
 
 
ExclusionCriteria 
Details  1).Currently undergoing desensitizing treatment.
2). Caries, Pulp pathologies, defective restorations,fracture
3). Chronic severe periodontal disease.
4). Uncontrolled systemic diseases.
5).patients having pacemakers.
6).Pregnant and/or lactating women.
7). Usage of analgesic, anticonvulsants, sedatives, tranquilizers, and anti inflammatory drugs within 72 h.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to evaluate reduction in VAS score  baseline, immediately after the treatment, 1 week, 1 and 3 months of the recall period. 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in tactile sensitivity  baseline, immediately after the treatment, 1 week, 1 and 3 months of the recall period. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   15/06/2024 
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="1"
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  DATA WILL BE AVAILABLE WITH PRIMARY INVESTIGATOR/ SCIENTIFIC QUERY CONTACT PERSON

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The perplexing problem of dentin hypersensitivity (DH) has long bemused the dental profession. It is one domain where the elusive “gold standards” for its management has not yet been achieved.

Difficulties in the treatment of the DH gave rise to many protocols and therapeutic procedures which are currently being used for the improvement of DH treatment.

NaF (Sodium Flouride) Iontophoresis a method where fluoride is transferred deep into the dentinal tubules under electrical pressure. This causes calcium fluoride precipitation, which decreases fluid movement induced by stimuli, reducing dentin hypersensitivity.

Use of Laser provides an innovative and quicker treatment which results in minimal side effects and safe for the patients. Laser stimulates the odontoblasts, produces reparatory irregular dentin and obliterates the dentinal tubules which reduces the dentinal hypersensitivity. Diode Laser has specific wavelengths (655 nm to 980 nm) resulting safe for the patient and causing minimum side effects or damage to the pulp, compared to powerful systems such as Er, Cr:YSGG or Er: YAG lasers.

 

Thus, the aim this study is to evaluate and compare the efficacy of diode laser and Iontophoresis with 2% NaF gel in the treatment of dentinal hypersensitivity.

 
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