| CTRI Number |
CTRI/2025/11/097706 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study For The Treatment Of Patients Having Sensitive Teeth With The Help Of Newer Materials To Reduce Sensitivity Of Teeth |
|
Scientific Title of Study
|
A Randomized Clinical Study On Effectiveness Of Light Cured Ormocer Based Desensitizer And Diode Laser Alone Or In Combination For The Treatment Of Dentine Hypersensitivity |
| 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 Pradnya Nagmode |
| Designation |
Professor and Guide |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
SMBT Dental College and Hospital Ghulewadi Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9970156112 |
| Fax |
|
| Email |
pradnyanagmode2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Mayurbhai Viramgama |
| Designation |
Student |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
SMBT Dental College and Hospital Ghulewadi Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8668859660 |
| Fax |
|
| Email |
ishaviramgama4041@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Nagmode |
| Designation |
Professor and Guide |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
SMBT Dental College and Hospital Ghulewadi Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9970156112 |
| Fax |
|
| Email |
pradnyanagmode2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital Ghulewadi Amrutnagar Sangamner Dis : Ahmednagar Maharashtra India 422608 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council Of Medical Research (ICMR) V. Ramalingaswami Bhawan Ansari Nagar New Delhi India 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 PRADNYA NAGMODE |
SMBT Dental College and Hospital |
101, Department of Conservative Dentistry and Endodontics Ghulewadi Sangamner Ahmednagar Maharashtra India 422608
Ahmadnagar
MAHARASHTRA |
9970156112
pradnyanagmode2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Dental College and Hospital Sangamner |
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 |
Diode Laser |
Diode laser will be applied perpendicular to the long axis of the tooth at a distance of 10-12 mm point by point |
| Intervention |
Light Cured Ormocer Based Desensitizer |
Light Cured Ormocer Based Desensitizer will be applied on all dentine surfaces for 20 s. It will be dispersed with a faint air jet and Light-cured with a conventional polymerization device for 10 s. A second layer will be applied and dispersed with a faint air jet and will be light-cured for 10 s |
| Intervention |
Light Cured Ormocer Based Desensitizer along with Diode Laser |
Light Cured Ormocer Based Desensitizer will be applied on all dentine surfaces for 20 s. It will be dispersed with a faint air jet and Light-cured with a conventional polymerization device for 10 s. A second layer will be applied and dispersed with a faint air jet and will be light-cured for 10 s followed by Diode laser application perpendicular to the long axis of the tooth at a distance of 10-12 mm point by point |
| Comparator Agent |
Placebo paste |
Under proper isolation with cotton rolls, placebo paste will be applied using rotating rubber cup. After 1 minute the surfaces will be slightly washed with water.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects should be dentally mature in the age group of 19-60 years and have sensitive teeth with a clinical diagnosis satisfying the definition of dentin hypersensitivity.
2.Patient with at least one hypersensitive tooth following air blast and tactile at the screening and baseline visit with baseline VAS score more than 4, in each of the four quadrants.
3.Patient complaining of sensitivity due to mechanical, thermal or chemical stimuli.
4.Early non-carious lesions including those which do not require restorations.
5.Good oral hygiene.
6.No previous treatment for dentinal hypersensitivity.
7.Both males and females included.
8.Readiness of the patient to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Medical and pharmacotherapeutic histories that may compromise the protocol including the chronic use of anti-inflammatory, analgesic and psychedelic drugs.
2.Benign or malignant pathological oral lesions.
3.Caries in the selected or adjacent teeth.
4.Teeth with non-carious lesions with pulpal involvement.
5.Congenital enamel or dentin defects.
6.Crazed or hypoplastic teeth.
7.Pregnancy or breast feeding.
8.Allergies and idiosyncratic responses to product ingredients.
9.Systemic conditions that are etiological or predisposing to dentin hypersensitivity. (e.g chronic acid regurgitation)
10.Excessive dietary or environmental exposure to acids and Eating disorders.
11.Teeth or supporting structures with any other painful pathology or defects.
12.Teeth restored in the preceding 5 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Dentine Hypersensitivity |
1. Baseline
2. Immidiately after treatment
3. 4 Weeks after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="6"
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
|
This study is a randomised, Single blind, parallel group, multiple arm trial comparing the effectiveness of light cured ormocer based Desensitizer and Diode Laser when used alone or in combination in 15 patients comprising 60 samples at baseline, Immediately after treatment and after 4 weeks for reducing dentinal hypersensitivity which is a common problem among dental patients. The Primary outcome measures will be reduction in hypersensitivity. |