| CTRI Number |
CTRI/2025/04/085719 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of dentinal hypersensitivity with different treatment modalities |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of LASER, desensitizing agent,
and their combined effects on dentinal hypersensitivity– 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 Sadhna Manglani |
| Designation |
MDS student |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Room number-9, Department of conservative dentistry and endodontics, Government dental college and Hospital Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09770248890 |
| Fax |
|
| Email |
dr.sadhnamanglani03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Asthana |
| Designation |
Head of Department and Professor |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Room number 9, Department of conservative dentistry and endodontics, Government dental college and Hospital, Civil hospital campus, Asarwa
Ahmadabad
GUJARAT
380005
India |
| Phone |
09824440656 |
| Fax |
|
| Email |
geetasthana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhna Manglani |
| Designation |
MDS Student |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Room number 9, Department of conservative dentistry and endodontics, Government dental college and Hospital Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09770248890 |
| Fax |
|
| Email |
dr.sadhnamanglani03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governmental Dental College and Hospital, civil hospital campus, Asarwa, Ahmedabad, Gujarat, India, 380016
|
|
|
Primary Sponsor
|
| Name |
Ahmedabad dental corporation |
| Address |
Shahibaug hospital, Asarwa , Ahmedabad |
| Type of Sponsor |
Other [Ahmedabad dental corporation] |
|
|
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 Sadhna Manglani |
Government dental college and Hospital, Civil hospital campus, Asarwa |
Room no. 9, Department of Conservative dentistry and Endodontics
Ahmadabad
GUJARAT |
09770248890
dr.sadhnamanglani03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare and assess the decrease in symptoms of dentinal hypersensitivity in total 14 days. This will be including 3 interventions for each group i.e. on Day1, Day7 and Day14 |
Group I – Nanohydroxyapatite based desensitising agent was applied for 15 min and then rinsed
Group II – DIODE LASER (980nm) application was done twice for 60 s in noncontact mode
Group III - Nanohydroxyapatite based desensitising agent was applied for 15min then DIODE LASER (980nm) application was done twice for 60 s in noncontact mode
|
| Comparator Agent |
To compare and assess the decrease in symptoms of dentinal hypersensitivity using desensitizing agent, Diode laser and in combination. |
To compare the duration of symptom relief provided by each treatment protocol over a defined follow-up period.
To explore the potential synergistic effects of combined treatment protocols compared to single treatments
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with no systemic diseases were recruited.
Patients with a sensitivity score of 2 or more to the air blast stimulus as recorded on verbal analog scale.
|
|
| ExclusionCriteria |
| Details |
Carious teeth, restored teeth, and patients undergoing desensitizing therapy.
Allergic to ingredients used in the study.
Chronic users of anti-inflammatory and analgesic drugs.
Fractured or cracked teeth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the symptoms of dentinal hypersensitivity with each treatment protocol over a defined follow-up period.
|
Baseline(Day1), Day7, Day14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in the Verbal Analog Score of with each treatment protocol over a defined follow-up period.
2. Potential synergistic effects of combined treatment protocols compared to single treatments.
|
Baseline(Day1), Day7, Day14 |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/05/2025 |
| 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 (DHS) represents as a pain of short and sharp nature but of rapid onset, this arises from exposed dentin in response to osmotic, thermal, chemical, or mechanical stimuli which cannot be attributed to any other form of dental disease or defect. The Hydrodynamic theory given by Brännström in 1964 is the most accepted theory. It states that an immediate pain response occurs when any stimuli cause rapid displacement of dentinal fluid within the tubules resulting in excitation of intradental nerves. Based on this theory, successful treatment of DHS depends on preventing or reducing fluid flow within the tubules. Thus, using different means to seal the open orifices of the dentinal tubule is the chief requirement. The present study will aim to compare and assess the decrease in symptoms of dentinal hypersensitivity using desensitizing agent, Diode laser and in combination. |