| CTRI Number |
CTRI/2024/06/068236 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of Post operative pain using three different types of obturation technique. |
|
Scientific Title of Study
|
Evaluation of Postoperative Pain between Three Different Obturation Techniques in Patients undergoing Root Canal Treatment: A Randomized Controlled 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 |
Dr PRAVIN KUMAR |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute
of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAVIN KUMAR |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute
of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragati Agarwal |
| Designation |
Post Graduate Student |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Endodontic section
Department of Dentistry, Block 2A, OPD Building, All India Institute
of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9589967246 |
| Fax |
|
| Email |
pragatiagarwal1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni
Basni,Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Pravin Kumar |
All India Institute of Medical Sciences, Jodhpur |
Endodontic Section
Block 2A second floor
Department of Dentistry,
Marudhar Industrial
Area, 2nd Phase, M.I.A.
1st Phase, Basni,
Basni, Jodhpur,
Rajasthan 342005
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9818402220
kumarpr@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
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, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carrier Based technique |
After completion of the Root canal space preparation in the first appointment, in the second appointment,
the size of the canal will be assessed with a Thermafil verifier instrument which will help in the selection of the appropriate- sized obturator.
The canals will be dried and a sealant will be applied with the help of lentulospiral. The silicon stopper on the carrier will be adjusted to the working length and the carrier will be loaded into the ThermaPrep Plus Oven for approximately 10 seconds. The carrier will be inserted into the canal and placed up
to the working length with a firm uniform apical pressure
without rotating. The position of the carrier will be verified radiographically and
the gutta-percha shall be allowed to cool for 2–4 minutes before resecting the carrier at the level of the canal orifice. Post-endodontic restoration will be placed. An intraoral periapical radiograph will be taken to ensure the quality of the obturation and to identify the apical sealing and presence or absence of extrusion of the obturating material. The total duration of such intervention will be 1 week. |
| Comparator Agent |
Cold lateral compaction |
After completion of the root canal space preparation in the first appointment, in the second appointment, the root canal will be first dried with absorbent paper points.The size of the spreader will be determined by the width of the prepared canal and the lateral fit of the primary cone; the greater the space between the canal wall and the butt end of the gutta-percha, the larger (wider) the spreader will be used.Selection of the master cone gutta-percha will be done(similar to the master apical file (MAF) size).The master cone placement will be confirmed with a radiograph. Sealer application on the canal walls will be performed using a Lentulo spiral.Minimal judicious force will be used on the spreader during the compaction process in order to avoid root fractures.
Additional secondary gutta-percha cones will be inserted
until the spreader cannot be reinserted, an indication
that the root canal is fully compacted laterally. Post-endodontic composite restoration will be placed.Intraoral periapical radiograph will be taken to ensure quality of the obturation ,to identify the apical sealing and presence or absence of extrusion of the obturating material. The total duration will be 1 week. |
| Intervention |
Thermoplastic backfill technique |
After completion of the root canal space preparation in the first appointment, in the second appointment,canal will be dried with absorben paper points, sealer will be coated on to the canal walls with the help of lentulospiral.The thermoplastic backfill technique will be accomplished by the use of device that will allow the operator to extrude thermoplastic gutta-percha into the canal apico-coronally after heating it to a certain temperature. The gutta-percha pellets will loaded into a handheld gun. A gauge needle that is appropriate will be chosen and placed 3-5 mm short of the working length. By exerting pressure on the trigger, gutta-percha will slowly injected, and as the canal fills apically, the needle will be gradually withdrawn. The
gutta-percha will be then compacted using pluggers of appropriate size. The rest of the canal can will be filled in one to two increments
using the same technique.Post-endodontic restoration will be placed.Intraoral periapical radiograph will be taken to ensure quality of the obturation, to identify the apical sealing and presence or absence of extrusion of the obturating material. The total duration of such intervention will be 1 week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy patients without systemic diseases or
allergic reactions (ASA I and ASA II).
2. Single-rooted teeth with a single root canal.
3. Patients with no signs of immature apex or
previously initiated RCT.
4. No associated mobility of the tooth.
5. Patients with symptomatic irreversible pulpitis or
apical periodontitis.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had taken analgesic or anti-
inflammatory drugs within the last 12 hours of
root canal obturation.
2. Pregnancy or lactating mother.
3. Radiographic evidence of resorption
(internal/external), root fracture, calcification,
advanced bony destruction.
4. Previously treated or initiated tooth.
|
|
|
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 |
To comparatively evaluate three different obturation techniques in causing postoperative pain following root canal therapy.
|
Post-operatively -6 hrs, 24 hrs, 48 hrs, 72 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine which obturating technique leads to minimum apical extrusion and overfilling.
|
Post-operatively |
To compare the effectiveness of three distinct obturation techniques in filling and sealing the apical ramifications.
|
Post-operatively |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Clinicians should have enough knowledge regarding factors causing postoperative pain and its management. Between 3% and 69.3% of patients experience pain in the first 24 to 48 hours after root canal treatment. Postoperative pain can result from a variety of factors, including grossly inflamed pulp status, inaccurate working length determination, faulty or erroneous irrigation protocols, and improperly executed obturation techniques. The obturating materials provoke an inflammatory reaction when they come into contact with the vital tissues through the lateral or apical canals and may therefore influence the pain following root canal therapy. Thus, the present clinical study aims to comparatively evaluate three different obturation techniques for causing minimum postoperative pain in patients with symptomatic irreversible pulpitis or apical periodontitis following root canal therapy. A total of 75 patients who meet the inclusion criteria will be enrolled for the clinical trial and three different obturation techniques (Cold lateral compaction, Thermoplastic backfill technique, Carrier-Based technique) will be used to obturate the canal as per manufacturer instructions. |