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CTRI Number  CTRI/2024/11/077272 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing two treatment protocols in reducing Dentin hypersensitivity 
Scientific Title of Study   Comparative Clinical Evaluation of two In-office Desensitizing agents in Reducing Dentin hypersensitivity- A Randomised Split Mouth Clinical 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 Juttu Shirisha 
Designation  MDS 
Affiliation  Panineeya Institute of dental sciences and research centre 
Address  Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad

Hyderabad
TELANGANA
500060
India 
Phone  9177311966  
Fax    
Email  shirishaj321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Umrana Faizuddin 
Designation  Professor 
Affiliation  Panineeya Institute of dental sciences and research centre 
Address  Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad

Hyderabad
TELANGANA
500060
India 
Phone  9949244418  
Fax    
Email  umranaafroz@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Umrana Faizuddin 
Designation  Professor 
Affiliation  Panineeya Institute of dental sciences and research centre 
Address  Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad

Hyderabad
TELANGANA
500060
India 
Phone  9949244418  
Fax    
Email  umranaafroz@rediffmail.com  
 
Source of Monetary or Material Support  
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad  
 
Primary Sponsor  
Name  Dr Juttu Shirisha 
Address  Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad  
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 Juttu Shirisha  Panineeya Institute of Dental Sciences and Research Centre  Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
Hyderabad
TELANGANA 
9177311966

shirishaj321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  cervical abrasion 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resin based varnish  single coat applied on the buccal side of the cervical area of the teeth and light cured for 15 seconds  
Comparator Agent  sodium fluoride based Varnish  Applied on the buccal surface of teeth and left for initial set for 10 minutes 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients from 30 to 60 years of age with excellent systemic health conditions with history of dentin hypersensitivity with Preoperative Schiff scale of ≥1 and at least two or more lesions in two different quadrants of the mouth are included in this study

 
 
ExclusionCriteria 
Details  Patients who have used desensitizing toothpaste in the last 3 months, receiving periodontal therapy with cervical defects greater than 2mm horizontally, allergic to ingredients used in the study, chronic users of anti-inflammatory and analgesics, pregnant or nursing with uncontrolled systemic diseases, with fractured or cracked teeth are excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of varnishes  baseline score, immediately, after 1 week  
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of varnishes  after 1 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   N/A 
Date of First Enrollment (India)   20/12/2024 
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 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  

Dentin hypersensitivity is a painful sensation commonly reported in daily practice.It is defined as a short, sharp pain that arises from exposed dentin in response to non-noxious stimuli, typically thermal, evaporative, tactile, osmotic or chemical, and that cannot be ascribed to any other form of dental defects or diseases. 

The frequency of Dentin hypersensitivity increases with age; the majority of patients affected by Dentin hypersensitivity are between their second and fifth decades of life, with top events extending from 30 to 40 years of age. Females are more likely to be affected. The condition generally involves the facial surfaces of teeth at the cervical aspect and is very common in premolars and canines.

The treatments for dentin sensitivity include professional in-office, at-home or over-the-counter desensitizing agents. Application of desensitizing agents is the most frequently used non-invasive treatment for Dentin hypersensitivity, especially in cases with limited or invisible dental hard tissue loss or cervical exposure. The active compounds found in desensitization products could either block the openings of dentinal tubules thereby isolating the tubule contents or might directly desensitize the pulpal nerves.

In-office topical application of desensitizing agents used earlier worked by tubular occlusion. Nowadays, newer agents having remineralization properties and superior bond strength came into existence. Shield Force Plus (resin-based) and MI varnish (sodium fluoride-based) are such desensitizing agents.

Shield Force Plus, a one component self-etching light-cured dental adhesive based on Self Reinforcement technology, characterized by an Self Reinforcing monomer component that penetrates into the tooth substrate resulting in multi-point interactions with apatite calcium, and three-dimensional cross-linking reactions. It forms a thin, and uniform hard coating on the tooth surface for superior bond strength to the tooth substance.

MI varnish, which is used for in�’office treatment, acts by plugging the dentinal tubules and is a calcium phosphate�’based varnish. It is a 5% sodium fluoride�’based varnish with phosphopeptides (CPP) which stabilizes the amorphous calcium phosphate phase to deliver the bioavailable calcium, phosphate, and fluoride ions to the tooth surface to promote remineralization of the tooth structure.

The aim of this study is to assess the effectiveness of two in-office desensitizing agents in reducing dentinal hypersensitivity in patients with mild-to-moderate sensitivity with a 1-month follow-up.

 
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