| CTRI Number |
CTRI/2024/05/067589 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of diode laser and seventh generation dentin bonding agent in the treatment of dentinal hypersensitivity |
|
Scientific Title of Study
|
Dentin cryesthesia - Evaluating the efficacy of diode laser and seventh generation bonding agent : A clinical 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 |
Khushi Patel |
| Designation |
PG Student |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9904070787 |
| Fax |
|
| Email |
khushipatel1901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Shah |
| Designation |
Professor and PG Guide |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376121229 |
| Fax |
|
| Email |
drshah16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Patel |
| Designation |
PG Student |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9904070787 |
| Fax |
|
| Email |
khushipatel1901@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Khushi Patel |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad |
| 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 Khushi Patel |
College of Dental Sciences and Research Centre |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT |
9904070787
khushipatel1901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, College of Dental Sciences and Research Centre |
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 |
Biolase epicX with tip E4-4EZ with specifications of 2W power, 980nm, keeping the tip 2mm away from the tooth with continuous mode and continuously moving the tip all over the lesion for 30 seconds |
| Comparator Agent |
Seventh generation dentin bonding agent |
3M ESPE Single bond universal applied in scrubbing motion with microapplicator tip for 20 seconds followed by drying with gentle air blow and light cured for 20 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with good general health with no allergies to commercial dental products
No use of desensitizing toothpaste within prior 3 months
No restoration or decay of tested teeth
Hypersensitivity due to etiologies like abrasion, parafunctional habits, gastric or emotional diseases or frequent ingestion of acidic foods
Gingival recession of Miller class 1 and 2 |
|
| ExclusionCriteria |
| Details |
Non vital teeth or vital teeth with cracks, restorations, carious lesions
Occlusal facets
Use of any desensitizing toothpaste within last 3 months
Teeth with periapical pathology
Patients with chronic disease with daily pain episodes, those under anticonvulsive, analgesic, antihistaminic, tranquillizer, anti inflammatory or sedative medication in last 72 hours
Prior periodontal surgery in last 6 months
Fixed partial units and prosthetic clasp
Pregnant and nursing females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respond to air blow and tactile stimulus |
Immediate postoperative, 7 days, 14 days, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Having any complication of severe sensitivity within follow up period time, all the measures were recorded in patients charts |
Immediate postoperative, 7 days, 14 days, 1 month, 3 months, 6 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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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 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
|
Dentin Hypersensitivity is a very common clinical condition of the teeth characterized by acute, sharp pain arising from the exposed dentin, most commonly in response to thermal, tactile or chemical stimuli and which cannot be linked to any other pathological changes in the tooth or the environment. There is still no promising solution for it due to little knowledge about its etiology and predisposing factors. The aim of this study is to compare the efficacy of diode laser and seventh generation dental bonding agent in the treatment of dentin hypersensitivity. |