| CTRI Number |
CTRI/2024/12/078613 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative pain & Motion kinematics |
|
Scientific Title of Study
|
Evaluation of postoperative pain and its relationship with different motion kinematics: A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Susmitha M |
| Designation |
Student |
| Affiliation |
Meenakshi Ammal Higher education & Research institute |
| Address |
Department of conservative dentistry and endodontics, postgraduate section, room no. 9 Alapakkam Main road , Janaki nagar, Maduravoyal, Chennai, Tamil Nadu, 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9551223250 |
| Fax |
|
| Email |
susmitha98sus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandini suresh |
| Designation |
professor |
| Affiliation |
Meenakshi Ammal Higher education & Research institute |
| Address |
Department of conservative dentistry & Endodontics , postgraduate section , Room No.9,Alapakkam Main road , Janaki nagar, Maduravoyal, Chennai, Tamil Nadu, 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susmitha M |
| Designation |
Student |
| Affiliation |
Meenakshi Ammal Higher education & Research institute |
| Address |
Department of conservative dentistry & Endodontics,Postgraduate section,Room No. 9,Alapakkam Main road , Janaki nagar, Maduravoyal, Chennai, Tamil Nadu, 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9551223250 |
| Fax |
|
| Email |
susmitha98sus@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal dental college and hospital,Alapakkam main road ,Maduravoyal ,India,chennai-600095 |
|
|
Primary Sponsor
|
| Name |
Susmitha M |
| Address |
No. 77B/14B,Lalitha puram,New boag Road,T.Nagar,Chennai-600017 |
| 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 |
| DrSusmitha M |
Meenakshi Ammal Higher education & Research institute |
Department of conservative dentistry & Endodontics, post graduate section, Room No. 9, Alapakkam Main road , Janaki nagar, Maduravoyal, Chennai, Tamil Nadu, 600095
Chennai
TAMIL NADU |
09551223250
susmitha98sus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Meenakshi Ammal dental college & hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endodontic files |
one reci-reciprocating files will be used to clean and shape the canals which can range for 5 to 10 mins-which is the duration of this intervention
|
| Comparator Agent |
Endodontic files |
Trunatomy-rotary files will be used to clean and shape the root canals which can range from 5 to 10 mins
|
| Comparator Agent |
Endodontic files |
Twisted file adaptive-rotary files will be used to clean and shape the root canals which can range from 5 to 10 mins
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals (ASA Class I) diagnosed with symptomatic irreversible pulpitis in mandibular molar teeth, in the age group of 18-45 years, Periapical index less than 2 |
|
| ExclusionCriteria |
| Details |
Teeth that are non-vital, teeth that require Endodontic retreatment, Root resorption, open Apex cases , Patient with any uncontrolled systemic disease , Periodontally compromised teeth , Periapical index more than 2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This information would be useful for clinicians to better understand the efficiency of file systems with different motion kinematics for postoperative pain. |
2 4 6 12 24 48 72hrs & 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| his information would be useful for clinicians to better understand the efficiency of file systems with different motion kinematics for postoperative pain. |
2 4 6 12 24 48 72hrs & 7 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
06/01/2025 |
| 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
|
Endodontic postoperative pain is described as a
sensation of discomfort following the completion of root canal treatment and is
experienced by 25-40% of patients. New thermomechanically
treated nickel-titanium (NiTi) alloys and varied kinematics have been
incorporated into the manufacture and use of endodontic instruments One
RECI files are new heat treated C-wire files introduced into the market by (OR;
MicroMega, Besançon, France). The C-wire technology is intended to boost
instrument flexibility and centering ability One RECI files have a
variable off-centered cross section, starting as a triple helix and
progressively changing to an S-shape towards the shank.TruNatomy rotary system
(Dentsply Sirona, Ballaigues, Switzerland) is a set of instruments made of a
maximum fluted diameter of 0.8-mm,Instruments present a variable taper and an
off-centered parallelogram cross-sectional design to preserve the radicular
dentin during mechanical preparation, Instruments present a variable taper
and an off-centered parallelogram cross-sectional design to preserve the
radicular dentin during mechanical preparation.The Twisted File Adaptive (TFA)
System (SybronEndo, Orange, CA) is composed of a combined continuous rotation
and a reciprocating motion in which the file rotates CW, and depending on the
load on the file, it adapts and reverses CCW by coasting in a reciprocating
motion Hence, the objective of this randomized clinical trial is to
comparatively evaluate the effect of motion kinematics on postoperative pain
and healing following primary endodontic treatment using One RECI, TruNatomy and Twisted File Adaptive
file systems.
|