| CTRI Number |
CTRI/2018/03/012667 [Registered on: 19/03/2018] Trial Registered Prospectively |
| Last Modified On: |
20/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Sodium Hypochlorite, Diode Laser And Photodynamic Therapy In non vital teeth undergoing root canal treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Disinfecting Potential of Sodium Hypochlorite, Diode Laser And Photodynamic Therapy In Non- vital Teeth With or Without Periapical Rarefaction - A Double Blind Randomized Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranav Vanajassun Purushothaman |
| Designation |
Assistant Professor |
| Affiliation |
SRM Dental college |
| Address |
Department of Conservative Dentistry and Endodontics,
SRM Dental college
Bharathi Salai
Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9884683059 |
| Fax |
|
| Email |
docpranav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranav Vanajassun Purushothaman |
| Designation |
Assistant Professor |
| Affiliation |
SRM Dental college |
| Address |
Department of Conservative Dentistry and Endodontics,
SRM Dental college
Bharathi Salai
Ramapuram, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9884683059 |
| Fax |
|
| Email |
docpranav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Rai |
| Designation |
Post graduate student |
| Affiliation |
SRM Dental College |
| Address |
SRM Dental college
Bharathi Salai
Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
sadhana.rai1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics; SRM Dental College, Ramapuram, Chennai, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sadhana Rai |
| Address |
SRM Dental College
Bharathi Salai
Ramapuram |
| 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 Sadhana Rai |
Department of Conservative Dentistry and Endodontics |
2nd Floor,
Department of Conservative Dentistry and Endodontics,
SRM Dental college
Bharathi Salai
Ramapuram, Chennai
Kancheepuram
TAMIL NADU |
9940292745
sadhana.rai1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sodium Hypochlorite 2.5%
Diode Laser 808 nm
Diode laser 660 nm
|
Root canals will be disinfected using sodium hypochlorite or diode laser 808nm or diode laser 660nm after cleaning and shaping. |
| Comparator Agent |
Sodium hypochlorite, diode laser 808nm and diode laser 660nm |
the disinfection potential of sodium hypochlorite, diode laser 808nm and diode laser 660nm will be compared and evaluated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with PAI score 1, 2 and 3
2.Patients categorized under ASA 1and 2
3.Patients with non vital teeth with or without periapical rarefaction in single rooted teeth with closed apices, all indicated for root canal treatment.
|
|
| ExclusionCriteria |
| Details |
1.Patients categorized under ASA 3 and 4.
2.Patients with PAI score 4 and 5.
3.Patients who underwent 1 week of systemic antibiotic therapy.
4.Patients with non vital teeth with severe root curvature of more than 45 degree.
5.Patients with endo-perio lesions
6.Patients with root canal attempted teeth, fracture teeth, calcified root canals, root resorption and re-infection in endodontically treated teeth.
|
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce microbial load in root canals of non vital teeth with or without periapical lesion using proposed disinfecting protocols. |
5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To promote periapical healing, no clinical signs and symptoms of pain, swelling, tender on percussion and sinus tract. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/04/2018 |
| Date of Study Completion (India) |
13/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Double Blind Randomized Clinical Study to compare and evaluate the Disinfecting Potential Of Sodium Hypochlorite, Diode Laser And Photodynamic Therapy in Non-vital Teeth With Or Without Periapical Rarefaction. The study will be conducted inSRM Dental college, Ramapuram and the microbial analysis will be done in Sri Ramachandra Dental College, Porur. The primary outcome is to reduce microbial load in root canals in nonvital teeth with or withour periapical lesion using Sodium Hypochlorite, Diode Laser and Photodynamic therapy. Secondary outcome is to promote periapical healing, no clinical signs and symptoms of pain, swelling, tender on percussion and sinus tract.
This in vivo study follows double blind randomized clinical trial performed by 3 operators. 1st operator diagnoses and allots the patients randomly in either one of the disinfection group after diagnosis.The respective disinfection protocol groups were as follows: • Group I: 5.25% Sodium hypochlorite (n=15) • Group II: 808nm Diode laser (n=15) • Group III: 660nm Diode laser with methylene blue dye(n=15) The 2nd operator does the access opening using a sterile round bur and rotary hand piece. Canals were negotiated using 10# k hand file and working length determination was done using apex locator. Followed by cleaning and shaping with rotary Protapers (F4 size) along with EDTA and copious irrigation of sterile saline. Disinfection of the root canals were done using one of the disinfecting protocols according to the respective allotted group. • Group I: Canals irrigated with 1mL of 5.25% NaOCl for 2 minutes using 27 guage needle. • Group II: Canals irradiated with 808 nm diode laser with 0.1-7mW for 30 seconds • Group III: Photosensitizer(Methylene blue) allowed to remain in the canal for 5mins, followed by irradiation with 660nm diode laser for 4mins. The 3rd operator takes the pre instrumentation and post disinfection sample using paper points. The collected samples were subjected to flow cytometer in order to analyze pre and post live microbial count. |