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CTRI Number  CTRI/2018/01/011303 [Registered on: 12/01/2018] Trial Registered Retrospectively
Last Modified On: 10/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of the Effect of Two Professional topical desensitising solutions (Super Seal® Vs Fluor Protector N) on Dental Hypersensitivity. 
Scientific Title of Study   Comparative Clinical Evaluation of the Efficacy of a Single Topical Application of Potassium Oxalate Desensitising Solution (Super Seal®) Vs Fluoride Varnish (Fluor Protector N) on Dentinal Hypersensitivity: an In Vivo and In Vitro study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parkavi A 
Designation  first year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9619307113  
Fax    
Email  drparx1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mala Dixit Baburaj 
Designation  Professor and Head of Department 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parkavi A 
Designation  first year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9619307113  
Fax    
Email  drparx1@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental College, Mumbai 
 
Primary Sponsor  
Name  Parkavi A 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central - 400008.  
Type of Sponsor  Other [self-sponsored by primary investigator] 
 
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 
Parkavi A  Nair Hospital Dental College, Mumbai.  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.
Mumbai
MAHARASHTRA 		 9619307113

drparx1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dentinal hypersensitivity patients with atleast one hypersensitive tooth on contralateral side with a visual analogue score of 3 or more,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoride varnish  Commercially available Fluoride Varnish (Fluor Protector N), single time topical application for a duration of 60 seconds. Concentration of Fluoride is 7700 ppm in a homogenous solution. The participants are followed up for a period of 1 month after the intervention. 
Intervention  Potassium Oxalate Desensitising Solution   commercially available Potassium Oxalate Desensitising Solution (Super Seal®), single time topical application for a duration of 60 seconds.The paticipants of the study are followed up for a period of 1 month after the intervention. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients in good systemic health
2. Self complaint of dentinal hypersensitivity following a cold stimuli such as ice cream,
iced drink, or a rapid jet of cool air to a particular tooth or teeth
3. The patients ranged in age from 20 to 60 years
4. Patients with at least one sensitive tooth on contralateral sides with a VAS score of ≥3
5. Patients with gingival recession having dentinal hypersensitivity
6. Patients with vital teeth
7. Patients with a minimum of 10 teeth in their total dentition
8. Cooperative patients who can be motivated to maintain good oral hygiene.
 
 
ExclusionCriteria 
Details  1. Previous treatment for hypersensitivity within the last six months
2. Restorative work performed on the hypersensitive teeth within the last 6 months
3. Topical fluoride treatment within the last 6 months
4. Periodontal surgery or root planing on the hypersensitive tooth within the last 6
months.
5. Known allergy to Potassium oxalate or Fluoride or any other drug allergy
6. Large carious lesions or cracked tooth structure
7. Patients with orthodontic appliance, crowns, bridges in the area of sensitivity.
8. Previous endodontic treatment on the selected teeth.
9. Pregnant and/or lactating mothers.
10. Patients with any bleeding disorders.
11. Patient on anticoagulant therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
visual analogue score of pain  at baseline, one week post-application and 4 weeks post application. 
 
Secondary Outcome  
Outcome  TimePoints 
tubular occlusion  1, 3 , 5 ,7, 10 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 15/09/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a split mouth, single bllind, interventional, case control study. The aim of the study is to evaluate and compare in vitro and in vivo the efficacy of a single topical application of Potassium Oxalate Desensitising Solution (Super SealR) Vs Fluoride varnish (Fluor Protector N) on dentinal hypersensitivity. 50 patients with the chief complaint of dentinal hypersensitivity with atleast one hypersensitive teeth on contralateral side of the arch with visual analogue score of 3 or more will be enrolled in the study after oral prophylaxis and baseline examination. sensitive teeth on the right side of the arch will be treated with a single topical application of Potassium Oxalate Desensitising Solution (Super SealR) and the sensitive teeth on the left side of the arch will be treated with a single topical application of Fluoride varnish (Fluor Protector N). the patients will be evaluated for sensitivity using visual analogue scale postoperatively at one week and four weeks. In vitro study will be done on human extracted teeth sections using SEM analysis. 
RESULT: 
IN VIVO STUDY: RESPONSE TO WATER: 1 week post treatment , reduction in dentinal sensitivity to water stimulus by Potassium Oxalate Desensitising Solution (Super SealR) was significantly better than Fluoride varnish (Fluor Protector N) and the reduction in dentinal sensitivity to water stimulus 1 month post treatment between Potassium Oxalate Desensitising Solution (Super SealR) and Fluoride varnish (Fluor Protector N) was not significantly different and both were found to be equal.
IN VIVO STUDY - RESPONSE TO AIR - 1 week post treatment, reduction in dentinal sensitivity to air stimulus by Potassium Oxalate Desensitising Solution (Super SealR) was significantly better than Fluoride varnish (Fluor Protector N) and the reduction in dentinal sensitivity 1 month post treatment to air stimulus between Potassium Oxalate Desensitising Solution (Super SealR) and Fluoride varnish was not significantly different and both were equal.
IN VITRO STUDY - After treatment the dentinal tubule occlusion of both the solutions were found to be equal.
 
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