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CTRI Number  CTRI/2024/11/077231 [Registered on: 22/11/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Desensitizing ability of different desensitizing agents 
Scientific Title of Study   Desensitizing ability of different desensitizing agents-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  Dr Sheba rani katikala 
Designation  pg student 
Affiliation  Dr ntruhs vijayawada 
Address  Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.

West Godavari
ANDHRA PRADESH
534003
India 
Phone  7093271897  
Fax    
Email  drshebakatikala406@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srihari devalla. 
Designation  Professor 
Affiliation  St. Joseph Dental College & Hospital, Duggirala, Eluru 
Address  Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.

West Godavari
ANDHRA PRADESH
534003
India 
Phone  9440134678  
Fax    
Email  drsriharidevalla@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srihari devalla. 
Designation  Professor 
Affiliation  St. Joseph Dental College & Hospital, Duggirala, Eluru 
Address  Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.


ANDHRA PRADESH
534003
India 
Phone  9440134678  
Fax    
Email  drsriharidevalla@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru. 
 
Primary Sponsor  
Name  Sheba rani katikala 
Address  Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru. 
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 Sheba rani katikala  St. Joseph Dental College & Hospital  Department of Conservative Dentistry and Endodontics- 2nd floor, room no 5
West Godavari
ANDHRA PRADESH 
7093271897

drshebakatikala406@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ST JOSEPH DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K030||Excessive attrition of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control (no treatment)  comparision of desensitizing ablity of nanohydroxy apatite gel, curodont and gluma with control (no treatment) 
Intervention  nanohydroxy apatite gel, curodont and gluma  comparision of desensitizing ablity of nanohydroxy apatite gel, curodont and gluma using visual analogue scale score for a period of 3 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants included in the study had the following conditions:
1.Good general health without any known allergy to commercial dental products.
2.The teeth are free of decay or restoration.
3.Patients have not previously received any dentine hypersensitivity treatments.
4.Patients have no history of receiving any teeth whitening treatments.
5.The degree of tooth initial sensitivity should be 3 or higher based on VAS.
 
 
ExclusionCriteria 
Details  Participants excluded from the study had the following conditions:
1.use of medications that could interfere with the perception of pain including chronic
use of anti-inflammatory, analgesic, anticonvulsant, sedative, or other psychotropic drugs;
and pregnancy or breastfeeding and patients with chronic diseases.
2.Patients who have been using desensitizing toothpaste or mouthwash in the last 3 months.
3.Patients who had underwent periodontal surgery in the last 6 months.
4.Teeth with evidence of pulpitis, Vital or non-vital teeth that have cracks, previous large restorations, deep abrasions requiring Class V fillings, or had any fractured or endodontically treated teeth carious lesions, gingival recession of more than 3 mm or active periodontal disease.
5.Teeth with deep carious lesions in the vicinity of sensitive teeth that their pain can be confused with tooth sensitivity.
6.Patients whose sensitive teeth are adjacent together.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Evaluation and comparison of desensitizing ability of nanohydroxyapatite, curodont, and gluma.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="71"
Sample Size from India="71" 
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)   04/12/2024 
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="1"
Months="0"
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  
The aim of the study is to evaluate the desensitizing ability of nano-hydroxyapatite based curodont and gluma -in vivo and to compare the desensitizing efficacy of nano-hydroxyapatite based, curodent and
gluma. patients will be taken from OPD of department of Conservative Dentistry and Endodontics in St. Joseph Dental College, Eluru. Signed informed consent will be taken from all the patients who are diagnosed with dentinal hypersensitivity. 
 Participants included in the study had the following conditions:

1. Good general health without any known allergy to commercial dental products.

2. The teeth are free of decay or restoration.

3. Patients have not previously received any dentine hypersensitivity treatments.

4. Patients have no history of receiving any teeth whitening treatments.

5. The degree of tooth initial sensitivity should be 3 or higher based on VAS.

Participants excluded from the study had the following conditions:

1. use of medications that could interfere with the perception of pain including chronic

use of anti-inflammatory, analgesic, anticonvulsant, sedative, or other psychotropic drugs

and pregnancy or breastfeeding and patients with chronic diseases.

2. Patients who have been using desensitizing toothpaste or mouthwash in the last 3 months.

3. Patients who had underwent periodontal surgery in the last 6 months.

4. Teeth with evidence of pulpitis, Vital or non-vital teeth that have cracks, previous large restorations, deep abrasions requiring Class V fillings, or had any fractured or endodontically treated teeth carious lesions, gingival recession of more than 3 mm or active periodontal disease.

5. Teeth with deep carious lesions in the vicinity of sensitive teeth that their pain can be confused with tooth sensitivity.

6. Patients whose sensitive teeth are adjacent together.

After recording the initial tooth sensitivity, the patients were randomly divided and intervened with following desensitizing agents i.e, nanohydroxyapatite gel, curodont, and gluma and will be followed up for a period of 3 months. the results will be statistically analyzed.
 
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