| CTRI Number |
CTRI/2025/08/093565 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing dentin bonding agent and desensitizing agent for dentin hypersensitivity using iontophoresis device for 1 month follow up |
|
Scientific Title of Study
|
Effect of dentin bonding agent and different desensitizing agent in treatment of dentin hypersensitivity using iontophoresis:a split mouth randomized controlled 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 |
JESSY CHANDRIKA CHILAKAPATI |
| Designation |
Student |
| Affiliation |
Gitam dental college and hospital |
| Address |
Department of conservative dentistry room no 4 Gitam dental college and hospital Rushikonda visakhapatnam Andhra Pradesh 530001 India
Department of conservative dentistry room no 4 Gitam dental college and hospital Rushikonda visakhapatnam Andhra Pradesh 530001 India
Visakhapatnam
ANDHRA PRADESH
530001
India |
| Phone |
9014893272 |
| Fax |
|
| Email |
drjessychandrika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Konagala Ravi Kumar |
| Designation |
Professor |
| Affiliation |
Gitam dental college and hospital |
| Address |
Department of conservative dentistry and endodontics Gitam dental college and hospital rushikonda visakhapatnam Andhra Pradesh 530001 India
Visakhapatnam
ANDHRA PRADESH
530001
India |
| Phone |
9493415354 |
| Fax |
|
| Email |
dr.ravikumar99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JESSY CHANDRIKA CHILAKAPATI |
| Designation |
Student |
| Affiliation |
Gitam dental college and hospital |
| Address |
Department of conservative dentistry room no 4 Gitam dental college and hospital Rushikonda visakhapatnam Andhra Pradesh 530001 India
Department of conservative dentistry room no 4 Gitam dental college and hospital Rushikonda visakhapatnam Andhra Pradesh 530001 India
Visakhapatnam
ANDHRA PRADESH
530001
India |
| Phone |
9014893272 |
| Fax |
|
| Email |
drjessychandrika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gitam dental college and hospital Visakhapatnam Andhra pradesh 530001 India |
|
|
Primary Sponsor
|
| Name |
JESSY CHANDRIKA CHILAKAPATI |
| Address |
Gitam dental college and hospital rushikonda Visakhapatnam Andhra Pradesh 530001 India |
| 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 |
| DR JESSY CHANDRIKA CHILAKAPATI |
Gitam dental college and hospital |
Department of conservative dentistry room no 4 Gitam dental college and hospital Rushikonda visakhapatnam Andhra Pradesh 530001 India
Visakhapatnam
ANDHRA PRADESH |
9014893272
drjessychandrika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent ethics committee of gitam dental college of hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of dentin bonding agent clear fill se bond and desensitizing agent densensiblize kf in treatment of dentin hypersensitivity using iontophoresis |
To compare the effect of dentin bonding agent clear fill se bond and desensitizing agent densensiblize kf in treatment of dentin hypersensitivity using iontophoresis at baseline ,1 months |
| Comparator Agent |
To compare the effect of dentin bonding agent clear fill se bond and desensitizing agent desensibilize KF in treatment of dentin hypersensitivity using iontophoresis |
comparison of clinical performance made at baseline ,1months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with no serious systematic diseases
Patients with at least two non carious symmetrical cervical lesions with depth 1mm on both sides either maxilla and mandible
Patients with cervical margins in dentin
Patients with vital pulp with absence of symptoms of pulpitis |
|
| ExclusionCriteria |
| Details |
Patients with a history of bruxism or para functional habits.
Teeth with chronic periodontal involvement and gingival inflammation.
Teeth that are grossly decayed.
Patients with very poor oral hygiene.
Patients suffering from psychological or neurological conditions.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of dentin bonding agent clear fill se bond and desensitizing agent densensiblize kf in treatment of dentin hypersensitivity using iontophoresis |
baseline ,1 months, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the effect of dentin bonding agent clear fill se bond & desensitizing agent densensiblize kf in treatment of dentin hypersensitivity using iontophoresis |
baseline , 1 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="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
|
20 patients with age groups between 20 - 60 years who have two non carious symmetrical cervical lesions with dentin hypersensitivity . To compare the effect of dentin bonding agent clear fill se bond and desensitizing agent densensiblize kf in treatment of dentin hypersensitivity using iontophoresis at baseline , 1 months, 2 months |