| CTRI Number |
CTRI/2024/05/067702 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
In- Vitro |
| Study Design |
Other |
|
Public Title of Study
|
How Laser and Ultrasound Help Dental Cleaners Reach Deep into Teeth: A Comparative Study |
|
Scientific Title of Study
|
Comparative Evaluation Of The Penetration Of Two Irrigation Solution Into Dentinal Tubules Using Diode Laser And Ultrasonic Activation:A Confocal Laser Microscopy 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 |
Palak Hirani |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe
Wardha MAHARASHTRA 442201 India |
| Phone |
09179174182 |
| Fax |
|
| Email |
palakhirani13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manoj Chandak |
| Designation |
Dean and Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe
Wardha MAHARASHTRA 442201 India |
| Phone |
9822693276 |
| Fax |
|
| Email |
drmanojchandak@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manoj Chandak |
| Designation |
Dean and Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
103 Dept of Conservative Dentistry and Endodontics SPDC Builiding DMIHER Sawangi Meghe
Wardha MAHARASHTRA 442201 India |
| Phone |
9822693276 |
| Fax |
|
| Email |
drmanojchandak@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and research Sawangi Meghe Wardha 442201 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha 442201 |
| Type of Sponsor |
Private medical college |
|
|
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 Palak Hirani |
103 1st floor Dept of Conservative Dentistry and Endodontics SPDC Building DMIHER Campus |
103 Dept of Conservative Dentistry and Endodontics SPDC Building DMIHER Campus Wardha MAHARASHTRA |
09179174182
palakhirani13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
its a pre- clinical study revolving around depth of penetration of irrigants through laser and ultrasonic mode of activation evaluating through confocal microscope |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Freshly Extracted single rooted permanent tooth with closed apex. |
|
| ExclusionCriteria |
| Details |
teeth displaying caries, restorations, visible cracks, abnormal morphology, multiple root canals, prior root canal treatment, developmental anomalies, external or internal resorption, multiple roots, and calcified root canals. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Penetration of Irrigant Solution via different activation techniques into Dentinal Tubules |
Results will be assessed at the end of 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2" Months="0" 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
|
Introduction
Endodontic therapy aims to eradicate
pulpal and periapical diseases by removing bacteria from root canals. Despite
thorough cleaning, smear layer obstructs canal disinfection. Root canal
preparation and irrigation, particularly with sodium hypochlorite, are
essential for debridement. However, conventional techniques may leave untouched
areas, necessitating innovative solutions like superoxidized water and
laser-activated irrigation for effective treatment.
Rationale
The effectiveness
of root canal treatment is contingent upon the success of the irrigating
solution and the mode used for its activation, which is directly manifested
through its ability to penetrate dentinal tubules. Thus, the focus of this
experimental in-vitro study is to find the most suitable irrigating solution
and an effective activation technique for better penetration into dentinal
tubules.
Objective: The study will comparatively
evaluate the
effect of diode laser and ultrasonic activation on dentinal tubule penetration of
oxidized water and sodium hypochlorite
Materials and
method- The
approach comprises categorizing 60 recently extracted single-rooted teeth, possessing
fully formed apical foramina and with intact
occlusal morphology,
into six primary groups according to distinct irrigation techniques.
Additionally, each group will be subdivided into two subsets based on the application
of two different irrigants, resulting in 10 teeth per subset. Decoronated specimens
will be injected with a particular Irrigant and activated using different techniques. Dentinal tubule
penetration of oxidized water by low-level laser therapy and ultrasonic will be
evaluated and compared using confocal laser microscopy.
Expected result- Dentinal tubule
penetration of oxidized water as an irrigant is more effective than that of
sodium hypochlorite using low-level laser therapy. |