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Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial

Primary Purpose

Root Canal Infection

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
root canal rotary files
Sponsored by
Tamil Nadu Dr.M.G.R.Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria included maxillary premolars with radiograph evidence of decay approximating the pulp with sound periodontal health.

Exclusion Criteria:

  • Exclusion criteria were patients not willing for recall visits, teeth not amenable to post-endodontic restoration, teeth with periapical radiolucencies, presence of additional roots or canal variations from conventional maxillary premolar anatomy, two or more adjacent teeth requiring root canal treatment, absence of occlusal contacts, premolars not sufficiently anaesthetized with 2 mL of local anesthetic solution, teeth with difficult canal anatomy (curvatures > 30°, radiograph evidence of pulp chamber and canal calcification, open apices) immunocomprimised patients, patients systemic ailments hindering single-visit root canal treatment and pregnant patients.

Sites / Locations

  • CSI college of dental sciences and researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Truanatomy rotary file

hyflex EDM rotary file

edge endo reciprocating rotary file

protaper gold rotary file

Arm Description

use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation

use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation

use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation

use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation

Outcomes

Primary Outcome Measures

post operative pain evaluation using different rotary instruments: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
post operative pain evaluation using different rotary instruments: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
post operative pain evaluation using different rotary instruments: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain

Secondary Outcome Measures

assessment of pain scale using different rotary instruments
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
comparing the pain scale experienced between male and female in VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain

Full Information

First Posted
December 3, 2020
Last Updated
March 29, 2021
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04655105
Brief Title
Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
Official Title
Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
May 3, 2021 (Anticipated)
Study Completion Date
June 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present clinical evaluation was planned for comparing the post-operative pain incidence in maxillary premolar teeth with acute irreversible pulpitis treated by recently introduced heat treated TruNatomy TM and other widely studied heat-treated files Hyflex EDM, Protaper Gold and one heat-treated reciprocating EdgeFile in single-visit root canal treatment.
Detailed Description
Essential component of successful root canal treatment is removal of pulp tissue remnants, microorganisms, and microbial toxins from root canal system. Machine assisted root canal preparation allows for faster and easier instrumentation. Flexible nickel-titanium (NiTi) root canal files have become indispensible with technological advancements in metallurgy and incorporation of several design features manufacturers have attempted to improve the efficiency of these instruments. 1 Thermomechanically treated NiTi has a modified phase composition compared to conventional NiTi files. These files contain varying amounts of R-phase and martensite in their alloy composition in clinical conditions. Increased proportion of martensite phase allows for more flexible files with enhanced cyclic fatigue resistance. Simultaneously endodontic motor have undergone significant enhancements regarding torque control and kinematics that are adjustable in several directions. 1 Yared (2008) introduced the concept of single file reciprocation which was based on balanced-force technique. Reciprocation motion have been shown to increase the cyclic fatigue resistance of NiTi instruments, also these motions have been associated with increased debris extrusion and post treatment discomfort. Recently TruNatomy TM files has been introduced with manufacturers claims of 0.8mm slim wire NiTi design with superior flexibility, off-centered cross-section, special heat-treated NiTi wire and regressive taper allowing for preservation of dentin and tooth integrity. Post operative pain following root canal treatment is influenced by number of factors; root canal file system and rotary kinetics on incidence and intensity of post-operative pain has been conflicting with certain evidence favoring full rotary motion whilst others recommend reciprocating motion. Sun et al. (2018) in their systematic review concluded that different type of full rotary root canal NiTi file system did not have significant influence on post-root canal treatment pain and reciprocation motion was associated with increased post treatment discomfort. These scientific studies involved comparing both conventional NiTi and heat-treated files. In this scenario the present clinical evaluation was planned for comparing the post-operative pain incidence in maxillary premolar teeth with acute irreversible pulpitis treated by recently introduced heat treated TruNatomy TM and other widely studied heat-treated files Hyflex EDM, Protaper Gold and one heat-treated reciprocating EdgeFile in single-visit root canal treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Truanatomy rotary file
Arm Type
Experimental
Arm Description
use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation
Arm Title
hyflex EDM rotary file
Arm Type
Experimental
Arm Description
use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation
Arm Title
edge endo reciprocating rotary file
Arm Type
Experimental
Arm Description
use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation
Arm Title
protaper gold rotary file
Arm Type
Active Comparator
Arm Description
use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation
Intervention Type
Device
Intervention Name(s)
root canal rotary files
Intervention Description
post operative pain evaluation using different rotary file system
Primary Outcome Measure Information:
Title
post operative pain evaluation using different rotary instruments: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
Time Frame
at 24 hrs
Title
post operative pain evaluation using different rotary instruments: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
Time Frame
at 48hrs
Title
post operative pain evaluation using different rotary instruments: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
Time Frame
at 7 days
Secondary Outcome Measure Information:
Title
assessment of pain scale using different rotary instruments
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
Time Frame
through study completion, an average of 1 week
Title
comparing the pain scale experienced between male and female in VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain
Time Frame
through study completion, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria included maxillary premolars with radiograph evidence of decay approximating the pulp with sound periodontal health. Exclusion Criteria: Exclusion criteria were patients not willing for recall visits, teeth not amenable to post-endodontic restoration, teeth with periapical radiolucencies, presence of additional roots or canal variations from conventional maxillary premolar anatomy, two or more adjacent teeth requiring root canal treatment, absence of occlusal contacts, premolars not sufficiently anaesthetized with 2 mL of local anesthetic solution, teeth with difficult canal anatomy (curvatures > 30°, radiograph evidence of pulp chamber and canal calcification, open apices) immunocomprimised patients, patients systemic ailments hindering single-visit root canal treatment and pregnant patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valliappan CT, post graduate (MDS)
Phone
08870558925
Email
vrvalliappan2@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anand Sherwood, MDS, Ph.D
Phone
9791443950
Email
anand.sherwood@gmail.com
Facility Information:
Facility Name
CSI college of dental sciences and research
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anand Sherwood
Phone
9791443950
Email
anand.sherwood@gmail.com
First Name & Middle Initial & Last Name & Degree
Valliappan C.T, post graduate

12. IPD Sharing Statement

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Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial

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