| CTRI Number |
CTRI/2025/11/096952 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TO know how effectively the bonding agents play role in reducing dentinal hypersensitivity or the patients who are having sensitivity of teeth to cold and hot stimuli |
|
Scientific Title of Study
|
Efficacy of seventh-generation bonding agent (3M Single Bond Universal) vs fifth-generation bonding agent (Nano-Bond) in patients with dentin hypersensitivity: a randomized controlled 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 |
Soumya |
| Designation |
Student |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Room number 5 Department of Periodontics Lenora institute of Dental Sciences Rajanagaram
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
7981026912 |
| Fax |
|
| Email |
pasalasoumya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandipati Sowmya Reddy |
| Designation |
Assistant professor |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Room number 5 Department of Periodontics Lenora institute of Dental Sciences Rajanagaram
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
6381512793 |
| Fax |
|
| Email |
sowmyareddy848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandipati Sowmya Reddy |
| Designation |
Assistant professor |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Room number 5 Department of Periodontics Lenora institute of Dental Sciences Rajanagaram
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
6381512793 |
| Fax |
|
| Email |
sowmyareddy848@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lenora institute of Dental Sciences
NH-16
Near HP petrol pump
Rajanagaram
Rajamahendravaram
Andhra pradesh 533294
India
|
|
|
Primary Sponsor
|
| Name |
Pasala Soumya |
| Address |
Room Number 5 Department of Periodontics Lenora institute of Dental Sciences Rajanagaram 533294 Andhra Pradesh India |
| Type of Sponsor |
Other [self ( Dr Soumya)] |
|
|
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 Soumya |
Lenora institute of Dental sciences |
Number 5 Department of Periodontics Lenora Institute of Dental Sciences Rajanagaram, Rajahmundry
East Godavari
ANDHRA PRADESH |
7981026912
pasalasoumya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
teeth sensitivity in recession patients
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Seventh-generation bonding agent |
Number 5 Department of Periodontics Lenora Institute of Dental Sciences Rajanagaram Rajahmundry
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients
Patients with class I gingival recession
|
|
| ExclusionCriteria |
| Details |
Smokers
Alcoholic patients
patients who are systemically ill |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Discomfort Interval Scale (DIS) Schiff Cold Air Sensitivity Scale |
Baseline
Immediately after placement
1 week
1 month
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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 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 (DH) is a prevalent clinical condition characterized by short, sharp pain arising from exposed dentinal tubules in response to external stimuli such as cold, heat, or tactile contact. This study aims to evaluate the efficacy of the seventh-generation bonding agent (3M single bond universal) vs. the fifth-generation bonding agent (Nano-Bond) in patients with dentin hypersensitivity. Each group was labeled only by product identifiers—Group I, Group II, and Group III—with packaging made to look identical to maintain blinding. The participants were unaware of the treatment they would receive, and the clinical provider was similarly blinded. Results indicate that 3M Single Bond Universal shows better reduction in dentin hypersensitivity than Nanobond over a 3-month period
|