FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068926 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of sodium flouride varnish laser and their combination to treat dental hypersensitivity. 
Scientific Title of Study   Comparative Evaluation Of Sodium Fluoride Varnish , Diode Laser and Their Combination To Reduce Dental Hypersensitivity: A Randomized Clinical 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  DEVASHREE 
Designation  MDS ,PG student 
Affiliation  K M shah dental college 
Address  Departemnet of conservative dentistry and endodontics,K M shah dental college and hospital,waghodiya road pipriya, vadodara
K M shah dental college and hospital,waghodiya road pipriya, vadodara
Vadodara
GUJARAT
391760
India 
Phone  9403907980  
Fax    
Email  devashreedarak7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDeebah Choudhary 
Designation  MDS,reader and PG guide 
Affiliation  K M shah dental college and hospital 
Address  department of conservative dentistry and endodontics,K M shah dental college and hospital,waghodiya road pipriya, vadodara
K M shah dental college and hospital,aghodiya road pipriya, vadodara
Vadodara
GUJARAT
391760
India 
Phone  9018872050  
Fax    
Email  deebahchoudhary@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr. Deebah Choudhary 
Designation  MDS,reader and PG guide 
Affiliation  K M shah dental college and hospital 
Address  Department of conservative dentistry and endodontics,K M shah dental college and hospital,waghodiya road pipriya, vadodara
K M shah dental college and hospital,waghodiya road pipriya, vadodara
Vadodara
GUJARAT
391760
India 
Phone  9018872050  
Fax    
Email  deebahchoudhary@yahoo.in  
 
Source of Monetary or Material Support  
Study will be conducted in K M shah dental college and hospital,sumandeep vidyappeth,vadodara 
 
Primary Sponsor  
Name  DrDevashree Darak 
Address  K m shah dental college and hospital, waghodiya road, vadodara 
Type of Sponsor  Other [self sponsored ] 
 
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 Devashree Darak  K m shah dental college and hospital  Department of conservative dentistry and endodontics,K M shah dental college and hospital, sumandeep vidyapeeth waghodiya road pipriya, vadodara
Vadodara
GUJARAT 		 8668839002

devashreedarak7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep vidyapeeth institutional ethical commi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  diode laser and combination of diode laser and flouride varnish  980 nm diode laser (DL) irradiation alone and 980 nm diode laser irradiation plus flourodip bioactive varnish combination . it is applied for 20 sec each cycle.Patients were evaluated after 24 hours and 1 week. Total duration of the study will be 3 months 
Comparator Agent  sodium flouride varnish  FluoroDip Bioactive is an alcoholic suspension of sodium fluoride and bio-glass in natural shellac with artificial flavoring. 1 ml of FluoroDip Bioactive varnish contains 50mg of sodium fluoride equivalent to 22.6 mg of fluoride.Patients were evaluated after 24 hours and 1 week. Total duration of study will be 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Systemically healthy both male and female patients between 18-70 years of age will be included in the study.
2. Patients with good oral hygiene, and clinically demonstrable dentinal hypersensitivitywill be included in the study.
3. Participants who have more than two sensitive teeth with a Schiff sensitivity score of ≥ 2 will be included in the study.
4. Patients with pre-operative VAS scoresof more than 3 on application of air/ cold will be included in the study.
 
 
ExclusionCriteria 
Details  1. Patients allergic to sodium fluoride or known allergy to any toothpaste containing fluoride will be excluded from the study.
2. Patients with any systemic or psychological diseases, constant use of analgesics, anti-inflammatory drugs, or allergic responses to dental products will be excluded from the study.
3. Teeth with carious lesions, defective restorations, fractures, prosthesis or orthodontics appliances, periodontal pockets, mobility, or evidence of pulpits will be excluded from the study.
4. In addition, those who have used any desensitizing agents or undergone any periodontal surgery in the last 6 months were excluded from the study
5. Patientstaking any analgesics, antibiotics, sedatives, and anti-anxiety drugs on regular basis or before 24 hours of treatment will be excluded.
6. Pregnant and lactating patients will be excluded from study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in post-opeative sensitivity after use of flouride varnish and diode laser .  24 hours and 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   25/06/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Dentin hypersensitivity is characterized by short, sharp pain arising from exposed dentin in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other dental defect or pathology. Dentin hypersensitivity can range from slight discomfort to extreme pain depending on the individual’s pain perception and tolerance. A variety of desensitizing agents have been recommended to reduce dentin hypersensitivity, which include nerve-desensitizing agents, protein-precipitating agents, dentin adhesive sealers, agents plugging dentinal tubules, and homeopathic agents.Sodium fluoride (NaF) was first proposed as a desensitizing agent by Lukomsky. Fluoride varnish was also favored by Porto et al. due to its ease of application and immediate action.In 1985, lasers were introduced as a potential desensitizing tool. The working parameters such as wavelength and the power density of the laser and the optical properties of the target tissue can lead to different tissue reactions.

. FluoroDip Bioactive is an alcoholic suspension of sodium fluoride and bio-glass in natural shellac with artificial flavoring. 1 ml of FluoroDip Bioactive varnish contains 50mg of sodium fluoride equivalent to 22.6 mg of fluoride.The interaction of laser with tissue leads to 17tissue reactions, which vary according to the laser wavelength and amount of energy applied.The mechanism of action for DH treatment consists of the chemical capacity of fluoride in reducing the fluid movements in the dentin tubules by means of the deposit of minerals on the open dentin tubules.Till date, numerous agents have been tried to eliminate this unpleasant symptom, in the form of mouthwashes, dentifrices, gel, ionic exchange gadgets (iontophoresis), etc. However, none of these agents are capable of delivering the drug constantly for long periods and require frequent revisits by patients or may take a long time to provide relief.Hence, the present study aimed to clinically evaluate the efficacy of 5% NaF varnish and 980 nm diode laser (DL) irradiation alone and in comparison with the combination of NaF varnish and 980 nm DL in the management of DH.Thus, this study aimed to assess the effectiveness of sodium fluoride varnish and diode laser and their combination to reduce dentinal hypersensitivity.

 
Close