| CTRI Number |
CTRI/2025/02/081127 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Clinical Efficiency Of Three Desensitizing Agents In Reducing Hypersensitivity
|
|
Scientific Title of Study
|
Comparative Clinical
Evaluation Of Three Desensitizing Agents In Reducing Dentin Hypersensitivity:A Randomised
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 |
Kunkati Mounika |
| Designation |
Post Graduate Student |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences Department Of Conservative Dentistry and Endodontics Room No 7 Gannavaram 521286
Krishna
Andhra Pradesh
NIL
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9553841068 |
| Fax |
|
| Email |
kunkatimounika1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Popuri Krishna Chaitanya |
| Designation |
Professor |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences Department Of Conservative Dentistry and Endodontics Room No 7 Gannavaram 521286
Krishna
Andhra Pradesh
NIL
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9703855345 |
| Fax |
|
| Email |
chaitanyapopuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Popuri Krishna Chaitanya |
| Designation |
Professor |
| Affiliation |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences |
| Address |
Drs Sudha & Nageswara Rao Siddhartha Institute Of Dental Sciences Department Of Conservative Dentistry and Endodontics Room No 7 Gannavaram 521286
Krishna
Andhra Pradesh
NIL
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9703855345 |
| Fax |
|
| Email |
chaitanyapopuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunkati Mounika Post graduate student Drs Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Department of Conservative Dentistry and Endodontics Room No 7 Gannavaram 521286 Chinaoutpalli Vijayawada Andhrapradesh |
|
|
Primary Sponsor
|
| Name |
Kunkati Mounika |
| Address |
Drs Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Department of Conservative Dentistry and Endodontics Room No 7 Gannavaram 521286 Chinaoutpalli Vijayawada Andhra Pradesh |
| Type of Sponsor |
Other [[SELF]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| KUNKATI MOUNIKA |
Drs Sudha And Nageswara Rao Siddhartha Institute Of Dental Sciences |
Room No 7,Department Of Conservative Dentistry And Endodontics, PG Block,Chinaoutpalli, Gannavaram,Vijayawada,Krishna District,Andhra Pradesh,India, 521286
Krishna
ANDHRA PRADESH |
9553841068
kunkatimounika1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Drs Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluma Desensitizer , Kulzer Mitsui Chemicals Group |
Gluma Desensitizer is a Glutaraldehyde based agent used to treat hypersensitive dentin.Gluma will be applied on hypersensitive dentin for 30-60secs and air dried ,then will be rinsed of .Hypersensitivity will be checked at time points at baseline, at 15min after Desensitizing agent application,at 1 week,4weeks,8weeks. |
| Intervention |
Tokuyama Shield Force Plus,Tokuyama Dental,Japan |
Tokuyama Shield Force Plus is a resin based Desensitizing agent will be applied on hypersensitive dentin and light cured for 10 secs.Hypersensitivity will be checked at baseline,at 15 mins after Desensitizing agent application,at 1 week,4 weeks,8 weeks. |
| Comparator Agent |
Voco Profluorid Varnish,Voco, Germany |
Voco Profluorid Varnish is a fluoride containing Dental Desensitizing varnish ,will be applied on hypersensitive dentin for 1 minute and allowed to wet by rinsing with water.Hypersensitivity will be checked at time points at baseline,at 15mins after Desensitizing agent application ,1 week,4 weeks,8 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with cervical abrasions,Erosions,Hypersensitive teeth.
Teeth with no caries,no cracks,no periapical lesions,no periodontal treatment in less than 6 months. |
|
| ExclusionCriteria |
| Details |
Non vital teeth,History of drug allergies,History of using Desensitising tooth paste/mouth wash,pregnant / lactating women. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| More than 75% of Patients receiving Desensitizing agents used in the study will be capable of having reduced hypersensitivity |
Hypersensitivity will be checked at baseline before Desensitizing agent application and 15 mins after Desensitizing Agent application,after 1 week,4 weeks,8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In more than 75% of patients there will be decrease in Dentin Hypersensitivity after treating with three types of Desensitizing agents used in the study |
Hypersensitivity will be checked at baseline before application of Desensitizing agent,at 15 mins after application of Desensitizing agent,at 1 week,4weeks,8weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="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
|
Dentinal Hypersensitivity is a common clinical condition associated with exposed dentinal surfaces.Due to cervical abrasion,Abfraction,erosion,attrition patients with Hypersensitivity are suffering with much discomfort to lead their daily life normally.Although many treatment options are available to treat Hypersensitivity,long term and immediate Hypersensitivity relief treatment remedies are of less significant in treating Dentin Hypersensitivity.Purpose of the study:So the current study aimed mainly to compare the clinical efficiency of three widely used Desensitizing agents in relieving hypersensitivity immediately at about 15min and upto how much durability the effect is by comparing baseline hypersensitivity levels before application of Desensitizing agent with that of 1 week,4 weeks,8 weeks. So that a better treatment option can be decided to treat Hypersensitivity to make patient comfort immediately and to a comparative longer duration. |