Root Canal InfectionNCT04655105
Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
A study testing root canal rotary files in people with Root Canal Infection, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- root canal rotary files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 3 Jan 2021to 3 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria included maxillary premolars with radiograph evidence of decay approximating the pulp with sound periodontal health.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
CSI college of dental sciences and research
Madurai, Tamil Nadu, 625001
Anand Sherwood, 9791443950, anand.sherwood@gmail.com
Valliappan C.T, post graduate
About this study
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.
Read the 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.
- Conditions
- Root Canal Infection
- Being tested
- root canal rotary files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal rotary filesDevice
post operative pain evaluation using different rotary file system
| Study group | Role | What they receive |
|---|---|---|
| Truanatomy rotary file | Experimental | use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation Receives: Device: root canal rotary files |
| hyflex EDM rotary file | Experimental | use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation Receives: Device: root canal rotary files |
| edge endo reciprocating rotary file | Experimental | use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation Receives: Device: root canal rotary files |
| protaper gold rotary file | Active comparator | use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation Receives: Device: root canal rotary files |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 hrs
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
Measured: at 48hrs
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
Measured: at 7 days
Secondary outcomes (2)
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
Measured: through study completion, an average of 1 week
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
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start3 Jan 2021
- Primary completion3 May 2021 (estimated)
- Study completion3 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valliappan CT, Tamil Nadu Dr.M.G.R.Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655105
- Sponsor's protocol ID
- TamilNadu
- Status last verified
- Mar 2021
- First submitted
- 3 Dec 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04655105
- Acronym / sponsor ID
- TamilNadu
- Conditions
- Root Canal Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 3 May 2021 (estimated)
- Study completion
- 3 Jun 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Truanatomy rotary file | Experimental | Device: root canal rotary filesuse of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation |
| hyflex EDM rotary file | Experimental | Device: root canal rotary filesuse of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation |
| edge endo reciprocating rotary file | Experimental | Device: root canal rotary filesuse of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation |
| protaper gold rotary file | Active comparator | Device: root canal rotary filesuse of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included maxillary premolars with radiograph evidence of decay approximating the pulp with sound periodontal health.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root canal rotary filespost operative pain evaluation using different rotary file system | Device | Truanatomy rotary file, edge endo reciprocating rotary file, hyflex EDM rotary file, protaper gold rotary file |
Primary outcome
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
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
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
2 secondary outcomes
assessment of pain scale using different rotary instruments
Time frame: through study completion, an average of 1 week
comparing the pain scale experienced between male and female in VAS score
Time frame: through study completion, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Related trials for Root Canal Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal rotary files in people with Root Canal Infection, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valliappan CT, post graduate (MDS) (08870558925, vrvalliappan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain evaluation using different rotary instruments: VAS score (time frame: at 24 hrs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.