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CTRI Number  CTRI/2024/03/064399 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of hypersensitivity with laser, toothpaste containing nanohydroxyapatite & its combination effect 
Scientific Title of Study   The Effect of Nanohydroxyapatite Containing Cream, Diode Laser and its Combination in relieving dentine 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  Konthoujam Bijaya devi 
Designation  Post Graduate 
Affiliation  Rajasthan University of Health and Sciences 
Address  Department of Conservative Dentistry and Endodontics Room number 5 Surendera Dental College and research Institute HH power house road, Sri Ganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  07005292408  
Fax    
Email  bijayakonthoujam.jb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neetu Jindal 
Designation  Professor and Head 
Affiliation  Rajasthan University of Health and Sciences 
Address  Surendera Dental College and Research Institute Sri ganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  09929854146  
Fax    
Email  drneetujindal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Konthoujam Bijaya Devi 
Designation  Post Graduate 
Affiliation  Rajasthan University of Health and Sciences 
Address  Department of Conservative Dentistry and Endodontics Room number 5 Surendera Dental College and research Institute HH power house road, Sri Ganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  07005292408  
Fax    
Email  bijayakonthoujam.jb@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Surendera Dental College and research Institute  
 
Primary Sponsor  
Name  Dr Konthoujam Bijaya Devi  
Address  Surendera Dental College and Research Institute HH garden power house road sri ganganagar Rajasthan 335001 
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 Konthoujam Bijaya devi  Surendera Dental College and Research Institute  Department of Conservative Dentistry and Endodontics room number 5
Ganganagar
RAJASTHAN 		 07005292408

bijayakonthoujam.jb@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pateient opting dental treatment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  combination of Nanohydroxyapatite containing cream and diode laser  duration for treatment first day one week and after two weeks pea size cream applied on affected teeth for 15 mins simultaneously laser applied for 10seconds in 940 nm wavelength and rinse 
Intervention  diode laser  duration for treatment first day one week and after two weeks 940nm wavelength for 10 second at affected teeth once at a time 
Intervention  Nanohydroxyapatite containing cream   duration for treatment first day one week and after two weeks a pea size of cream applied at affected teeth for 15 min and rinse 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Presence of minimum of two hypersensitive teeth
Hypersensitivity of teeth to tactile, air stimulus & cold water
Verbal analog scale VAS score more than 3
Gingival recession
Cuneiform defects-incorrect brushing technique
Patients in good systemic health with clinically elicitable DH
Absence of contraindications to the proposed therapies allergies to desensitizing agent

 
 
ExclusionCriteria 
Details  Dental caries, Wasting diseases, Fractures
Defective Fillings
Cracks of the tooth
Patients with clinical or radiograph evidence of pulp pathology
Any periodontal surgery-preceding 6 months
Deep periodontal pocket
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day  at baseline,1 week, 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day  At baseline a week two weeks 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
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)   30/03/2024 
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="2"
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  

 Aim:

The aim of this in vivo study is to evaluate the clinical efficacy of Nanohydroxyapatite containing cream, Laser & their combination effect in relieving dentine hypersensitivity.

 Objective:

   Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day.

 MATERIALS AND METHOD:

      The ethical committee approval is obtained from Institutional Ethical Committee (SDCRI/IEC/D/24/03) of Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, and trial will be registered in the Clinical Trials Registry India (CTRI).

 1. Source of Data:

      This study will be carried out in the Department of Conservative Dentistry & Endodontics and Department of Periodontology & Oral Implantology, Surendera Dental College & Research Institute, Sri Ganganagar, Rajasthan, India.

 2.  Armamentarium:

1.     Cotton roll

2.     Disposable applicator tip

3.     Explorer #23

4.     Disposable syringe (0.2ml)

3. Materials used:

1.     Nanohydroxyapatite containing cream (Fang, Couch Commerce Pvt. Ltd, India)

4. Equipments used:

        1. Diode Laser (Biolase 4 Cromwell Irvine, Made in USA)

5. Methods of Collection of Data:

A total 57 participants between the age group of 20-60years with the complaint of dentinal hypersensitivity will be included in this study.

 Inclusion criteria:

1.      Presence of minimum of two hypersensitive teeth

2.     Hypersensitivity of teeth to tactile, air stimulus & cold water

3.     Verbal analog scale (VAS) score >3

4.     Gingival recession

5.     Cuneiform defects-incorrect brushing technique

6.     Patients in good systemic health with clinically elicitable DH

7.     Absence of contraindications to the proposed therapies (e.g., allergies to desensitizing agent)

 Exclusion criteria:

1.     Dental caries, Wasting diseases, Fractures

2.     Defective Fillings

3.     Cracks of the tooth

4.     Patients with clinical or radiograph evidence of pulp pathology

5.     Any periodontal surgery-preceding 6 months

6.     Deep periodontal pocket

  The reported hypersensitive teeth in the subjects will be verified by light strokes of dental explorer along the cervical areas of all teeth present. This study will explain to the subjects and informed consent will be taken. The potential target sites will isolate with cotton rolls and sensitivity will be evaluated with 3 stimulus tests, each of these tests will be performed at the time gap of 5mins. 

·  Tactile test: Dental explorer will be gently run across the affected surface of the   tooth.

·       Air blast test: A blast of air from a 3-way dental syringe for 3sec from 1cm distance.

·       Cold water test: Ice cold water will be slowly expelled onto the tooth surface with disposable syringe (0.2ml).

     All the three tests will be applied in the ascending order of discomfort, i.e., tactile test (least disturbing) then air blast test and at last cold water test (most disturbing). The stimuli will be applied in the same order, at a time interval of 5 min each.

Sensitivity score will be recorded with verbal analog scale (VAS).

Verbal analog scale :- 0: No sensitivity;1–3 Mild sensitivity; 4–6 Moderate       sensitivity ;7–10: Severe sensitivity)

DIVISION OF GROUP:

57 participants will be randomly assigned to three experimental groups according to the material and equipment used. 19 patients in each group. 

Group 1: Nanohydroxyapatite containing cream (Fang Couch Commerce Pvt.Ltd,  India)

Group 2: Diode Laser (Biolase 4 Cromwell Irvine, Made in USA)

Group 3: Nanohydroxyapatite (Fang) + Diode laser (Biolase)

Procedure will be repeated at 1st,7th & 14th day for all the groups. The score will be recorded from all the participants of each group, after every session of application i.e, 1st, 7th, 14th day. 

The results will be analysed with one way ANOVA.


 

GROUP

MATERIAL

COMPOSITION

MODE OF APPLICATION

1.

FANG

 

Nanohydroxyapatite active ingrediants

Isolation with cotton roll. Pea sized desensitizing agent will be taken on the applicator tip & apply on the tooth surface & left for 15min and rinse

2.

LASER

 

Laser application with 940nm (2W), continuous non contact mode, in a distance of 1mm & in an oblique manner for 10 secs.

3.

FANG + LASER

 

Fang (nHAP) for 15min, then laser application will be done with the same parameter as mention above and rinse
 
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