| CTRI Number |
CTRI/2023/04/051599 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Post-operative pain using four different types of Root Canal Sealers. |
|
Scientific Title of Study
|
A Comparative Evaluation of Postoperative Pain in Patients undergoing Root Canal Treatment with Four Different Types of Sealers: A Randomized Controlled Trial |
| Trial Acronym |
|
|
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 |
| 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
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanya Sabharwal |
| 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 |
| Phone |
9971992059 |
| Fax |
|
| Email |
drsanya.sabharwal03@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 IIA Second Floor
Department of Dentistry
Marudhar Industrial
Area, 2nd Phase, M.I.A.
1st Phase, Basni,
Basni, Jodhpur,
Rajasthan 342005
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 |
AH Plus (Dentsply Sirona) |
It is a two paste system. Paste A: Epoxy resin, calcium
tungstate, zirconium oxide, silica, iron oxide. Paste B: Amines, calcium tungstate,
zirconium oxide, silica, silicon oil. Sealer will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times. Obturation will be completed by cold lateral condensation and post endodontic composite restoration will be placed. Intraoral periapical radiograph will be taken to ensure quality of the obturation and to identify presence or absence of extrusion of sealer. Post-operative pain evaluation will be done after 24hrs, 72hrs and 7 days. |
| Intervention |
BioRoot RCS (Septodont, India) |
It has two components. Powder - Tricalcium silicate, zirconium oxide, povidone. Liquid - Aqueous solution of Calcium Chloride and Polycarboxylate. Sealer will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times. Obturation will be completed by cold lateral condensation and post endodontic composite restoration will be placed. Intraoral periapical radiograph will be taken to ensure quality of the obturation and to identify presence or absence of extrusion of sealer. Post-operative pain evaluation will be done after 24hrs, 72hrs and 7 days. |
| Intervention |
Nishika Canal Sealer BG (Bioactive Glass) (Nippon Shika Yakuhin, Japan) |
It is a two-paste system. Paste A - Fatty Acids, Bismuth sub-carbonate, silicon dioxide. Paste B - Magnesium oxide, Purified water, Calcium silicate glass, silicon dioxide, others. Sealer will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times. Obturation will be completed by cold lateral condensation and post endodontic composite restoration will be placed. Intraoral periapical radiograph will be taken to ensure quality of the obturation and to identify presence or absence of extrusion of sealer. Post-operative pain evaluation will be done after 24hrs, 72hrs and 7 days. |
| Comparator Agent |
Tubliseal (Kerr Endodontics) |
It has two components. Base - Zinc oxide (60-100%),
White Mineral Oil (Petroleum) (5-30%), Barium Sulfate (5-30%), Starch (1-5%). Accelerator - Eugenol (30-60%), Thymol iodide (5-30%). Sealer will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times. Obturation will be completed by cold lateral condensation and post endodontic composite restoration will be placed. Intraoral periapical radiograph will be taken to ensure quality of the obturation and to identify presence or absence of extrusion of sealer. Post-operative pain evaluation will be done after 24hrs, 72hrs and 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 18 years to 65 years
2. Single rooted teeth with single apical exit.
3. Patients with no signs of immature apex or previously initiated RCT.
4. 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 lactation
3. Teeth with calcified canals
4. Teeth with periodontal diseases
5. Teeth with root resorption
6. Teeth with immature/open apex
7. 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 the incidence of post-operative pain using four different classes of sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) following root canal therapy. |
Post-operatively 24 hrs, 72 hrs, 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To comparatively evaluate the ability of four different classes of sealers for greater flow and to corelate incidence of apical extrusion of sealer with postoperative pain following root canal therapy. |
Post-operatively 24 hrs, 72 hrs, 7 days |
| To comparatively evaluate the radio-opacity of the obturated root canal with four different classes of sealers. |
Post-operatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative pain is an unwanted yet unfortunately a common sensation after endodontic treatment. The incidence of postoperative pain has been reported to range from 3% to 58%. There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or peri-radicular tissues, further irrigating solutions, medications and sealers can evoke pain by irritating the periradicular tissues. Any intracanal sealer that has a reduced the risk of extrusion into periapical tissues would help the patient and the clinician because such a root canal sealer could decrease postoperative discomfort. Thus, the present clinical trial aims to comparatively evaluate four different root canal sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) on causing post operative pain in patients with symptomatic irreversible pulpitis or apical periodontitis following root canal therapy. A total of 100 patients who meet the inclusion criteria will be enrolled for the clinical trial and four different sealers will be used belonging to four different compositions. These will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times. |