| CTRI Number |
CTRI/2024/09/074059 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY COMPARING ROOT CANAL TRANSPORTATION,CENTERING RATIO AND POSTOPERATIVE PAIN FOLLOWING GLIDEPATH PREPARATION BETWEEN TWO ROTARY AND MANUAL HANDFILES GROUP |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CANAL TRANSPORTATION,CENTERING RATIO AND POSTOPERATIVE PAIN FOLLOWING GLIDEPATH PREPARATION:A 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 MONISHA R |
| Designation |
PG STUDENT MDS |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
#348,6TH MAIN ROAD NAGENDRA BLOCK SRINAGAR,BANGLORE 50
THE OXFORD DENTAL COLLEGE AND HOSPITAL,BOMMONAHALLI,NH44,HONGASANDRA,BENGALURU,KARNATAKA
Bangalore
KARNATAKA
560050
India |
| Phone |
9972219694 |
| Fax |
080-26548658 |
| Email |
monisharv1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MONISHA R |
| Designation |
PG STUDENT MDS |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
#348,6th main road Nagendra block srinagar banglore 50
CLUSTER,BOMMANAHALLI,NH 44,HONGASANDRA,BENGALURU,KARNATAKA,560068
Bangalore
KARNATAKA
560050
India |
| Phone |
09972219694 |
| Fax |
08026548658 |
| Email |
monisharv1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MONISHA R |
| Designation |
PG STUDENT MDS |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
#348,6th main road Nagendra block srinagar banglore 50
CLUSTER,BOMMANAHALLI,NH 44,HONGASANDRA,BENGALURU,KARNATAKA,560068
Bangalore
KARNATAKA
560050
India |
| Phone |
09972219694 |
| Fax |
08026548658 |
| Email |
monisharv1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| The OXFORD DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr MONISHAR |
| Address |
#348,6TH MAIN ROAD NAGENDRABLOCK SRINAGAR BANGLORE 50 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| The oxford dental college and hospital |
cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 |
| Dr Srirekha A |
cluster, Bommanahalli, NH 44, Hongasandra, Bengaluru, Karnataka 560068 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| primary investigator |
The Oxford Dental college and hospital |
cluster,Bommanahalli,NH 44, Hongasandra,Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
9972219694
080-26548658
monisharv1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SYSTEMICALLY HEALTHY ADULTS AGED 18 TO 60 YEARS WITH IRREVERSIBLE PULPITIS OF TEETH . |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MANI JIZAI ROTARY Glidepath FILE,DENTSPLY TRUNATOMY GLIDEPATH ENDODONTIC ROTARY FILES |
EVALUATION OF CANAL TRANSPORTATION,CENTERING RATIO AND POSTOPERATIVE PAIN WITH REGARDS TO THESE TWO ROTARY FILES FOLLOWED BY COMPARING IT WITH MANUAL HAND FILES |
| Comparator Agent |
MANUAL HAND FILES |
COMPARING CANAL TRANSPORTATION,CENTERING RATIO,POSTOPERATIVE PAIN WITH MANUAL AND ROTARY GLIDE PATH INSTRUMENT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.systemically healthy adult patients aged 18 to 60 years with irreversible pulpitis in mandibular first molar indicated for root canal treatment.
2.mandibular first molar with mesial canal curvature between 10-30 degree.
3.Pulp diagnosed with irreversible pulpitis and normal periapical tissues |
|
| ExclusionCriteria |
| Details |
1.For standardization the canals that naturally had a smooth glide path to apex negotiated by #15k file or larger were excluded.
2.medically compromised patients.
3.pregnant women
4.previous endodontic treatment.
5.calcified canals.
6.Teeth with resorption
7.Immature apex |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluating canal transportation,cenetring ratio and postoperative pain in all the 3 groups and comparing 3 groups |
1)Before and After glidepath preparation of the canal .
2)postoperative pain would be assessed for 12,24,48 and 72 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of postoperative pain after glide path preparation with manual and rotary glidepath instrument. |
postoperative pain recorded at 12,24,48 and 72 hours. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
25/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/12/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This in vivo study will be conducted on human
mandibular first molar satisfying inclusion and exclusion criteria. Forty-five
patients between age group of 18 to 60years with mandibular first molar
indicated for root canal treatment and who signed informed consent will be
selected for the study.
Pre operative CBCT will be taken to determine root
curvature using Schneiders classification. Patients with mesial root of teeth
with canal curvature of 10 to 30 degree (moderately and severely curved root
canals) according to Schneider’s classification will be selected as samples for
the study (n =15).
Patients will be anaesthetized
with 1.8ml of 2% lignocaine with 1:80000 adrenaline by inferior alveolar nerve
block. After rubber dam isolation access cavity will be prepared using endo access bur using high speed
handpiece. The subjects will be randomly assigned to one of the three
groups according to the glide
path instrument by choosing a sealed
envelope containing the group name.
Group 1: Negotiation and glide path
preparation in the mesial canal in this group will be performed using hand
K files in the following order #10, # 15 and #20.
Group 2: A #10 hand K file will be used for
negotiation of mesial canal. Jizai glider of 013 tip size, 0.04 taper at 500
revolutions per minute with a torque setting of 3.0 Newton will be used for
glide path preparation.
Group 3: A #10 hand K file will be used for
negotiation of mesial canal. Trunatomy glider of size #17.02 progressive
taper at 500 revolutions per minute with a torque setting of 1.5 Newton will be
used for glide path preparation.
After completion of glide path preparation, each
canal will be rinsed with 3ml of 5.25% NaOcl. The CBCT scans of the patients
will be obtained and images will be saved. Canal transportation and centering
ratio in all groups will be calculated by the investigator.
CBCT measurements
To calculate the magnitude of transportation
of the mesiobuccal canal, the following formula will be used:
Pre and post instrumentation measurements of
canals were achieved using the three-dimensional CBCT. Canal transportation and
centering ratio will be calculated at three cross sections of 3, 6 and 9mm from
apical end using the following equation.
Magnitude of transportation
= (M1-M2) – (D1-D2).5
To calculate
centering ratio of mesiobuccal canal:
Centering ratio = (M1
-M2)/ (D1-D2)5
M1 represents the
distance between mesial portion of the root and uninstrumented canal, M2 is the
distance between mesial portion of the root and the instrumented canal. D1
represents distance between the distal portion of the root and uninstrumented
canal, D2 is the distance between the distal portion of the root and
instrumented canal.5
The pre and post instrumentation
CBCT images will be superimposed using the care stream software.
After glide path preparation further working
length determination, cleaning and shaping with their own respective file
systems, irrigation and obturation will be carried out. Patients will be
followed up to record postoperative pain.
Postoperative pain:
Postoperative pain will be recorded at 12, 24 ,48 and 72
hours after the treatment using a visual analogue scale (VAS).
|