CTRI Number |
CTRI/2023/07/054831 [Registered on: 06/07/2023] Trial Registered Prospectively |
Last Modified On: |
03/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical study on post operative pain after single sitting root canal treatment. |
Scientific Title of Study
|
Comparative Evaluation of Post-operative Pain Following Single Visit
Endodontics by using Two NiTi File Systems based on Different kinematics:
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 Rutuja Rajput |
Designation |
Post Graduate student |
Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
Address |
SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA
Raigarh MAHARASHTRA 410210 India |
Phone |
8169752300 |
Fax |
|
Email |
ruturajput30@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rutuja Rajput |
Designation |
Post Graduate student |
Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
Address |
SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA
Raigarh MAHARASHTRA 410210 India |
Phone |
8169752300 |
Fax |
|
Email |
ruturajput30@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anuradha Patil |
Designation |
Professor |
Affiliation |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE |
Address |
SECOND FLOOR ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Raigarh MAHARASHTRA
Raigarh MAHARASHTRA 410209 India |
Phone |
9819875730 |
Fax |
|
Email |
anuradhapatil32@gmail.com |
|
Source of Monetary or Material Support
|
Department of Conservative Dentistry and Endodontics, MGM Dental College and Hospital |
|
Primary Sponsor
|
Name |
MGM Dental College and Hospital |
Address |
MGM Dental College and Hospital Junction of NH-4 and Sion Panvel
Expressway, Sector-1, Kamothe, Navi Mumbai
|
Type of Sponsor |
Private hospital/clinic |
|
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 Rutuja Rajput |
MGM Dental College and Hospital |
Second floor, Room NO
9, Department of
Conservative Dentistry
and Endodontics,Post
Graduate section, MGM
Dental College and
Hospital
Raigarh
MAHARASHTRA Raigarh MAHARASHTRA |
8169752300
ruturajput30@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, MGM Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
TruNatomy Rotary NiTi file system |
root canals will be shaped using TruNatomy Rotary NiTi file system |
Comparator Agent |
WaveOne Gold reciprocating NiTi file system |
root canal will be shaped using WaveOne Gold reciprocating NiTi file system |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.All vital single-rooted teeth with irreversible pulpitis, whether associated with or without apical periodontitis, and mild to moderate pain (VAS value 5-74mm) indicated root canal treatment.2.Maxillary and mandibular premolars with single root and single canal.3.Patients with single rooted permanent teeth with periapical
radiolucency less than 1.5 mm as determined by an intraoral periapical (IOPA) radiograph.
4.Teeth with fully developed apex and straight canals with minimal curvature (0 to 10 degrees)
5.Teeth with healthy periodontium with periodontal probing depth
3
|
|
ExclusionCriteria |
Details |
1.Pregnant women and lactating mothers.
2. Patients with acute dentoalveolar abscess or cellulitis.
3. Patients presenting with severe pain (75-100mm).
4. Patients who have taken antibiotics and analgesics and corticosteroid in the past month. 5.Patients with known immunocompromised conditions (e.g., AIDS)
6.Patients who are known diabetic.
7.Patients with non-vital teeth and intraoral and extraoral sinus tract
8.Patients with radiographic evidence of radiolucency of more than 1.5 mm
9. Patients who are having teeth with Single roots having multiple canals, bifurcation and trifurcation of canals, canal aberration, calcified canals. open apex, root resorption. presence of root caries and multirooted teeth
10. Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth >3mm.
|
|
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 |
compare the of post-operative pain in
single-visit endodontics where canal instrumentation will be done using
two different rotary instrument systems. For each patient, the
preoperative and post-operative pain levels will be recorded by using a
visual analogue scale (VAS) |
The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit. |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
01/09/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Title: Comparative evaluation of post-operative pain following single visit endodontics using of two NiTi file systems based on different kinematics: A Randomized clinical study. Dental pain is most commonly induced by caries disease which is caused by specific types of bacteria. The caries disease elicits subsequent inflammation which might necessitate endodontic treatment the primary goal of endodontic treatment is to eliminate disease and manage the symptoms of the patient. Postoperative pain is an unpleasant sensory experience in patients undergoing endodontic treatment and has been reported in 25-40% of all endodontic patients. This pain is caused by the release of inflammatory mediators in the periradicular region due to increased vascular permeability and consequent oedema, which lead to the compression of nerve fibers in that region. Extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Clinically, a relationship exists between the presence of inflammatory mediators and the extrusion of debris, which depends on the preparation of the root canal system. Several clinical trials have compared the effect of reciprocating and rotation kinematics on postoperative pain and reported conflicting results, which might be attributed to the use of different instrumentation systems with different mechanical properties and designs. Therefore, further clinical data are necessary to elucidate the effect of endodontic instruments on postoperative pain. This study is a prospective, single-centre, double blind randomized clinical study with a concurrent parallel study design. Consecutive, Consenting sampling. Comparison will be done on of postoperative pain following single visit endodontics after the use of two NiTi file systems based on different kinematics: 80 patients will be selected on the basis of inclusion and exclusion criteria. Which further divide into 40 participants each. The patient will be allotted to one of the instrumentation techniques by random allocation using Graph pad by domatics software. Concealment allocation will be carried out by using sequentially numbered sealed opaque envelopes by a neutral observer. After randomization, allotted group will be written on a paper and kept in an opaque sealed envelope Group 1: Root canals will be prepared by TruNatomy rotary system. Group 2: Root canals will be prepared by WaveOne Gold reciprocating system. Cleaning and shaping of the canal will ne by done in which. The patient will be given post-operative instructions and will be recalled at the following intervals: 6 hours, 24 hours and 7 days, and evaluated for pain scale. Pain assessment will be done with the help of visual analogue scale (VAS). Participants will be asked to place a single mark on line to indicate current level of the pain. Using a ruler, distance was measured in mm from “no pain†anchor to mark on visual analogue scale line. Although all instrumentation techniques produce apical extrusion of debris, the difference lies in the ability of some techniques to extrude less debris than others. The rationale of this study is to evaluate the of post-operative pain in patients with chronic irreversible pulpitis following single-visit endodontics using two different nickel-titanium file systems based on different kinematics. This study would determine whether the use of the instruments would influence the occurrence of post-operative pain |