| CTRI Number |
CTRI/2017/02/007774 [Registered on: 03/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to evaluate the pain after root canal treatment by two diiferent rotary systems |
|
Scientific Title of Study
|
EVALUATION OF POST OPERATIVE PAIN IN SINGLE VISIT ROOT CANAL TREATMENT WITH PROTAPER NEXT AND M TWO ROTARY SYSTEMS IN ASYMPTOMATIC IRREVERSIBLE PULPITIS OF MULTIROOTED TEETH-A RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
EPSRT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Rama krishna |
| Designation |
post graduate student |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana dental college and hospital,chinthareddy palem
Nellore- 524002
andhra pradesh
c/o surendra,sai provisions and fancy stores
adhitya nagar ,balaji nagar
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
09704553652 |
| Fax |
09704553652 |
| Email |
ashok.surada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKMadhusudhana |
| Designation |
Professor and HOD |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana dental college and hospital,chinthareddy palem
Nellore- 524001
Department of conservative dentistry and endodontics
Narayana dental college and hospital,chinthareddy palem
Nellore- 524001
Nellore
ANDHRA PRADESH
524001
India |
| Phone |
9391046354 |
| Fax |
9391046354 |
| Email |
drmadhuk15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSuneel kumar C |
| Designation |
professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana dental college and hospital,chinthareddy palem
Nellore- 524002
Department of conservative dentistry and endodontics
Narayana dental college and hospital,chinthareddy palem
Nellore- 524002
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9966313666 |
| Fax |
|
| Email |
chinnisk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Narayana dental college and hospital |
| Address |
first floor,room no.6, department of conservative dentistry and endodontics,
Narayana dental college and hospital
|
| Type of Sponsor |
Other [private dental college and hospital] |
|
|
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 |
| S Rama krishna |
Narayana dental college and hospital |
first floor,room no.6
department of conservative and endodontics,
narayana dental college and hospital,
nellore, andhra pradesh
Nellore
ANDHRA PRADESH |
9704553652
ashok.surada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asymptomatic irreversible pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mtwo rotary file |
A new rotary file system developed to effectively cleaning and shaping of root canals |
| Intervention |
Protaper Next rotary file |
a newly developed rotary file for efficient cleanig and shaping of root canals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Multi rooted teeth with asymptomatic irreversible pulpitis with normal periapical radiographic appearance and periapical radiolucency less than 2mm will be scheduled for initial endodontic treatment.
2.Patients of age group between 18-50
3.Subjects who will show prolonged response even after the removal of the stimulus.
Patient who has the ability to understand the use of pain scales will be provided informed consent for endodontic treatment.
|
|
| ExclusionCriteria |
| Details |
1.Patients with sinus tract, periapical abscess or facial cellulitis.
2.Patient with known allergies, or any contraindication to opioid or non-opioid analgesics including aspirin or NSAIDs.
Patients with known allergy to local anaesthesia, sodium hypochlorite and chlorhexidine. Presence of systemic diseases like cardiovascular disease, renal disease, and any bleeding disorders or anti coagulant use with in last month.
3.Pregnants and lactating mothers.
4.Patients under pain medication for any other illness.
5. Patients who are unable or unwilling to complete the pain questionnaires;
6. Patients who are unwilling to sign consent for endodontic treatment
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post treatment pain evalution using visual analog scale after 8hours,12 hours,24hours,48hours,72hours |
post treatment pain evalution using visual analog scale 8hours,12 hours,24hours,48hours,72hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post treatment pain evalution using visual analog scale |
pain evaluation 24, 48, 72 hours after treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomised clinical trail to evaluate the post operative pain in single visit root canal treatment by using two different rotary instruments, that will be conducted in narayana dental college and hospital. the primary outcome measureswill be visual analog scale after 8, 24, 48, 72 hours |