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CTRI Number  CTRI/2024/01/061959 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of laser treatment alone and combined treatment of laser with toothpaste in the management of tooth sensitivity 
Scientific Title of Study   Effectiveness of Calcium Sodium Phosphosilicate based Desensitising Paste with Diode Laser Compared to Diode Laser Alone in the Management of Dentin Hypersensitivity- A Randomized Clinical Trial. 
Trial Acronym  not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  L Sai Sindhuja 
Designation  MDS PG first year student 
Affiliation  Government Dental College, Thiruvananthapuram 
Address  room no.38,dept of conservative dentistry & endodontics, government dental college, Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9640172966  
Fax    
Email  sindhulakamsani123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rejula F 
Designation  Associate professor 
Affiliation  Government Dental College, Thiruvananthapuram 
Address  Room.no.38,department of conservative dentistry and endodontics, government dental college, medical college road,thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9995227057  
Fax    
Email  rejula@hotmail.com  
 
Details of Contact Person
Public Query  
Name  L Sai Sindhuja 
Designation  MDS PG first year student 
Affiliation  Government Dental College, Thiruvananthapuram 
Address  Room.no.38,department of conservative dentistry and endodontics, government dental college, medical college road,thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9640172966  
Fax    
Email  sindhulakamsani123@gmail.com  
 
Source of Monetary or Material Support  
Government dental college,thiruvananthapuram,kerala 
 
Primary Sponsor  
Name  LSai Sindhuja 
Address  Government dental college, Thiruvananthapuram 
Type of Sponsor  Other [Dr. L.Sai Sindhuja (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 
DrLSai Sindhuja  Government Dental College  Room.no.38,department of conservative dentistry &endodontics,Government Dental College, Government Medical College, Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9640172966

sindhulakamsani123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Government Dental College,Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (2) ICD-10 Condition: K031||Abrasion of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  diode laser alone   treatment using GaAlAs Diode laser ( DenLase 980nm ) with three applications of one minute each to be done in only one appointment.  
Intervention  Novamin tooth paste in combination with diode laser  Treatment using application of Calcium Sodium Phosphosilicate based Desensitising Paste for one minute then rinse off, followed by use of GaAlAs Diode laser ( DenLase 980nm ) over the tooth for one minute.Like wise three applications are to be done in only one appointment  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients between 20-45 years of age
2. Patients with minimum of two hypersensitive teeth.
3. Defects <1mm loss of dentin in depth which did not require restorative
treatment.
4. Preoperative VAS score ≥ 2
5. Willing to give informed consent.
 
 
ExclusionCriteria 
Details  1.Teeth with caries, defective restorations, occlusal restorations, chipped teeth.
2. Deep periodontal pockets, periodontal surgery within 3 months, and subjects with orthodontic appliance or bridge work.
3. Use of desensitizing paste in the last 3 month.
4. Any gross oral pathology.
5. Subject on analgesics
6. Uncontrolled systemic disease.
7. Persons with mental health issues.
8. Pregnant or lactating females.
9.Patients undergone bleaching
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
visual analogue scale(VAS) score  Before and immediately after the treatment, again at 1st and at 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of pain assessment using visual analogue scale score  Before and immediately after the treatment, again at 1st and at 6th month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/02/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 (Others) -  nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  nil

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 01-08-2025?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Dentin hypersensitivity(DH) has been defined as short, sharp pain arising from exposed dentin as a result of various stimuli, such as heat, cold,chemical or osmotic, which cannot be ascribed to any other form of dental defect or pathology(Holland et al 1997).Its often referred as “common cold of dentistry” due to its high prevalence which ranges from 2.8% to 74%. But most treatments available till date doesn’t give immediate relief and are effective only for a short while. An inorganic amorphous calcium and sodium phosphosilicate belonging to the group of materials known as bioactive glass is commercially available with the brand name Novamin is commonly prescribed by the dentists to the patients suffering from DH. Laser desensitization is also an efficient alternative for the immediate treatment of hypersensitivity. So this study is to compare the effect of application of calcium sodium phosphosilicate ( CSPS )bioactive glass with diode laser and diode laser alone in the management of dentin hypersensitivity as measured by visual analogue scale ( VAS ) score using the evaluation tests immediately after treatment, at 1st month and at 6th month and to asess the best treatment outcome. The study design is double blinded randomized clinical trial where the patients and the outcome asessor will be blinded. Patients reporting to the out patient clinic in the Dept of Conservative Dentistry & Endodontics complaining about dentin hypersensitivity, who satisfies inclusion and exclusion criteria will be selected as subjects. The subjects will be allocated into two different groups randomly and the treatment will be given to each group respectively. In the treatment A group diode laser treatment is given alone. In the other treatment arm B group combined diode laser and bioactive glass treatment will be given. The subjects will be asked to score the elicitated pain based on the VAS. The VAS scoring will be done before the start of the treatment, immediately after the treatment, again at 1st month and at 6th month. Results will be drawn at the end of the study. 
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