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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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ClinicalTrials.gov Identifier: NCT04655105
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Valliappan CT, Tamil Nadu Dr.M.G.R.Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Root Canal Infection Device: root canal rotary files Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
Actual Study Start Date : January 3, 2021
Estimated Primary Completion Date : May 3, 2021
Estimated Study Completion Date : June 3, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Truanatomy rotary file
use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation
 Device: root canal rotary files
post operative pain evaluation using different rotary file system
Experimental: hyflex EDM rotary file
use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation
 Device: root canal rotary files
post operative pain evaluation using different rotary file system
Experimental: edge endo reciprocating rotary file
use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation
 Device: root canal rotary files
post operative pain evaluation using different rotary file system
Active Comparator: protaper gold rotary file
use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation
 Device: root canal rotary files
post operative pain evaluation using different rotary file system


Outcome Measures
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Primary Outcome Measures :
  1. post operative pain evaluation using different rotary instruments: VAS score [ Time Frame: at 24 hrs ]
    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

  2. post operative pain evaluation using different rotary instruments: VAS score [ Time Frame: at 48hrs ]
    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

  3. post operative pain evaluation using different rotary instruments: VAS score [ Time Frame: at 7 days ]
    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 :
  1. assessment of pain scale using different rotary instruments [ Time Frame: through study completion, an average of 1 week ]
    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

  2. comparing the pain scale experienced between male and female in VAS score [ Time Frame: through study completion, an average of 1 week ]
    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


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655105


Contacts
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Contact: Valliappan CT, post graduate (MDS) 08870558925 vrvalliappan2@gmail.com
Contact: Anand Sherwood, MDS, Ph.D 9791443950 anand.sherwood@gmail.com

Locations
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India
CSI college of dental sciences and research Recruiting
Madurai, Tamil Nadu, India, 625001
Contact: Anand Sherwood    9791443950    anand.sherwood@gmail.com   
Principal Investigator: Valliappan C.T, post graduate         
Sponsors and Collaborators
Tamil Nadu Dr.M.G.R.Medical University
More Information
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Responsible Party: Valliappan CT, post graduate student, Tamil Nadu Dr.M.G.R.Medical University
ClinicalTrials.gov Identifier: NCT04655105    
Other Study ID Numbers: TamilNadu
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations