CTRI Number |
CTRI/2021/01/030472 [Registered on: 14/01/2021] Trial Registered Prospectively |
Last Modified On: |
03/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare the pain after root canal treatment in decayed lower back tooth using two different instrumentation techniques INSTRUMENTATION TECHNIQUES |
Scientific Title of Study
|
“Evaluation of postoperative endodontic pain of rotary and reciprocation instrumentation techniques in necrotic, mandibular molars : A randomized, double blind clinical trialâ€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Catherine Eugine |
Designation |
Junior Resident |
Affiliation |
Govt.Dental College,Kottayam |
Address |
Govt.Dental College,Gandhinagar P.O.Kottayam
Kottayam KERALA 686008 India |
Phone |
8289878334 |
Fax |
|
Email |
catherineeugine2106@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR SHOBA K |
Designation |
Head of the department, Department of Conservative Dentistry and Endodontics |
Affiliation |
Govt.Dental College,Kottayam |
Address |
Govt.Dental College, Gandhinagar P.O. Kottayam
Kottayam KERALA 686008 India |
Phone |
9745205407 |
Fax |
|
Email |
drshobak@gmail.com |
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Details of Contact Person Public Query
|
Name |
DRSHOBA K |
Designation |
Head of the department, Department of Conservative Dentistry and Endodontics |
Affiliation |
Govt.Dental College,Kottayam |
Address |
Govt.Dental College, Gandhinagar P.O. Kottayam
Kottayam KERALA 686008 India |
Phone |
9745205407 |
Fax |
|
Email |
drshobak@gmail.com |
|
Source of Monetary or Material Support
|
Govt.Dental College,Gandhinagar P.O. ,Kottayam,Kerala |
|
Primary Sponsor
|
Name |
DRCATHERINE EUGINE |
Address |
GOVT.DENTAL COLLEGE,GANDHINAGAR P.O. KOTTAYAM |
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 |
DRCATHERINE EUGINE |
GOVT.DENTAL COLLEGE,KOTTAYAM |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS Kottayam KERALA |
8289878334
catherineeugine2106@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE,GOVT.DENTAL COLLEGE ,KOTTAYAM |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
ROOTCANAL TREATMENT USING RECIPROCATING INSTRUMENTATION TECHNIQUE |
ROOTCANAL TREATMENT IS DONE USING THE RECIPROCATING FILE,WAVE ONE |
Intervention |
ROOTCANAL TREATMENT USING ROTARY INSTRUMENTATION TECHNIQUE |
ROOTCANAL TREATMENT IS DONE USING THE ROTARY FILE,XP ENDOSHAPER |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
• Patients within age group of 25-45 years reporting at O.P of department of Conservative dentistry and Endodontics, Govt. dental college Kottayam.
• Patients with necrotic first or second mandibular molar with periapical lesions less than or equal to 2mm.
• Patients who sign informed consent forms outlining the purpose of study.
|
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ExclusionCriteria |
Details |
• Patients with history of medicine intake including corticosteroids, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) in the past 12 hrs.
• Patients suffering from any systemic disease.
Teeth with periapical lesions greater than 2mm,complicated anatomy (curves greater than 25 degrees), calcifications, internal and external resorption, open apices, periodontal disease, swelling and abscess, sensitivity to percussion.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Visual Analogue Scale Scorings-No pain, mild pain, moderate pain, and severe pain will be indicated by 0-mm, 1–54-mm,55–113-mm, and 114–170-mm divisions, |
6-, 12-, 18-, 24-, 48-, and 72-h postoperative intervals |
|
Secondary Outcome
|
Outcome |
TimePoints |
EVALUATION OF POSTOPERATIVE ENDODONTIC PAIN OF ROTARY AND RECIPROCATION INSTRUMENTATION TECHNIQUES |
6-, 12-, 18-, 24-, 48-, and 72-h postoperative intervals |
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
26/02/2021 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Post-endodontic pain is an annoying experience for the patient, undermining the patient-clinician relationship . Despite major improvements in armamentarium and pharmacologic interventions, pain after endodontic treatment remains to be a major problem. Dentin and pulp tissue debris, microorganisms and irrigating solutions may extrude into periradicular tissues during the preparation of root canals , thus causing complications such as postoperative pain and flare ups. All instruments and techniques that are used for root canal preparation may cause extrusion of different amounts of root canal contents outside the apical foramen . It has been reported that the amount of extruded contents may be influenced by the design and kinematics of endodontic files . The concept of single-file canal preparation was introduced in endodontics with the launch of Wave One instrumentation system. These instruments are fabricated with a nickel-titanium alloy called M-Wire using an innovative thermal treatment .The reciprocating motion involves an initial rotation of the instrument in a counter clockwise direction, during which the instrument penetrates and cuts the dentin, and then a rotation in the opposite direction, during which the instrument is released.Several studies have shown that a single file reciprocating system produced more debris extrusion than single file rotary systems. XP-endo Shaper (XP) , a novel snake-shaped NiTi rotary system is recently introduced. According to the manufacturer’s instructions , the file has a taper of 0.01 in its martensitic phase when it is cooled and the taper changes to 0.04 at body temperature (370C) by the molecular memory in austenitic phase. The metallurgic alloy provides high flexibility to the file and XP is expected to produce minimal stress on the dentin walls; resulting in minimal extrusion of debris. Periapical extrusion of debris is the main cause for postoperative pain after root canal treatment. The purpose of this investigation is to evaluate the post operative pain after root canal treatment in patients with necrotic mandibular molar teeth using two different instrumentation techniques: single file rotary and single file reciprocation . |