Vertical Fracture of Root of Tooth (Disorder)NCT05286073
Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files
A study testing Endodontic Root Canal Treatment in people with Vertical Fracture of Root of Tooth (Disorder), run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertical Fracture of Root of Tooth (Disorder)
- What is being tested?
- Endodontic Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 1 Feb 2022
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Extracted Human mandibular premolar canals that fulfill the following criteria were used.
- permanent teeth
- intact and fully formed apices
- straight and single rooted canal
- roots having similar diameter mesiodistally(2-4mm) and buccolingually(4-6mm)
Who cannot join
- Roots having following features were excluded;
- root caries
- roots with multiple canals
- previous root canal treatment done
- signs of calcification, internal and external root resorption
- cracks
Show all 9Show fewer
- fracture lines
- C-shaped canals
- Vertical Root Fracture
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots.
Read the detailed description
88 human extracted mandibular premolars will be selected. Teeth will be sectioned below cementoenamel junction to get 13mm from the apex of root. Roots will then be standardized according to buccolingual and mesiodistal widths and will be examined for fracture and craze lines. The roots will then be randomly divided into 3 experimental groups and 1 control group (n=22). Group 1 will be instrumented with Hyflex EDM. Group 2 will be instrumented with F6 Sky Taper. Group 3 will be instrumented with One Shape and Group 4 will be negative control group in which no instrumentation will be done. After performing rotary instrumentation, roots will then be obturated with respective GP and sealer. Samples will then be exposed to vertical load utilizing Universal Testing Machine till fracture occur which will be recorded in Newton(N).
- Being tested
- Endodontic Root Canal Treatment
- Keywords
- Hyflex EDM,F6 Sky Taper,One Shape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic Root Canal TreatmentProcedure or surgery
Root canal shaping procedures were performed. Irrigation was done after each three pecks of endodontic file. After instrumentation (Groups 1-3), the canals were dried with sterile paper points. The dentinal walls were then coated with Sealapex. For vertical root fracture resistance testing, sample preparation was done in acrylic blocks. Then roots were coated with polyvinylsiloxane impression material. After that roots were inserted again into acrylic resin blocks. The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine. 0.5 mm diameter round tip stainless-steel rod was fixed to the universal testing machine. The universal testing machine was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, until the root fractured. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
| Study group | Role | What they receive |
|---|---|---|
| Hyflex EDm | Experimental | The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm). Receives: Procedure: Endodontic Root Canal Treatment |
| F6 SkyTaper | Experimental | The canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm). Receives: Procedure: Endodontic Root Canal Treatment |
| One Shape | Experimental | Canals were prepared and shaped with single rotational file system One Shape with the sequence of Endoflare (12, 0.12), One G (18, 0.03) and One Shape (12.06) connected to endodontic motor with rotational speed of 400rpm and 4 Ncm torque as recommended by manufacturer. Receives: Procedure: Endodontic Root Canal Treatment |
| Control | No intervention | In the control group, no endodontic instrumentation and shaping was done in the canals. Only the necrotic pulp tissue was extirpated from the canals with the help of barbed broaches and then the specimens were analyzed for fracture testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Root Fracture Resistance
The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine one at a time. 0.5 mm diameter round tip stainless-steel rod was fixed to the upper stage of the universal testing machine (Instron, Canton, MA, USA). The rod was centered over the canal orifice of each root. The universal testing machine (Instron) was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, at a rate of 1.0 mm per min, until the root fractured. This point was verified by the computer monitoring the Instron testing machine; at the same time the crack was heard, the monitor showed a sharp drop in force. The test was terminated at this point and the force applied was recorded. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
Measured: 5 minutes
Secondary outcomes (1)
Crack pattern
crack pattern is complete/incomplete
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Feb 2019
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vertical Fracture of Root of Tooth (Disorder)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Samples were randomly divided in 4 groups. Random sampling was done with computer generated method. There were 3 working groups comprising of 22 canals and 1 negative control group having 22 canals.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urooj Musheer, Dow University of Health Sciences
- Investigators
- Farah Naz, BDS,FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286073
- Sponsor's protocol ID
- IRB-1658/DUHS/Approval/2020/
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pawar AM, Pawar MG, Thakur B, Banga KS, Luke AM. Resistance to fracture of teeth instrumented using novel EndoStar E5 rotary versus ProTaper NEXT and WaveOne file systems. J Conserv Dent. 2018 Jan-Feb;21(1):52-56. doi: 10.4103/JCD.JCD_216_16.
PubMed 29628648Pawar AM, Barfiwala D, Pawar M, Metzger Z, Kfir A, Jain N. Assessment of the fracture resistance of teeth instrumented using 2 rotary and 2 reciprocating files versus the Self-Adjusting File (SAF): An ex vivo comparative study on mandibular premolars. J Conserv Dent. 2016 Mar-Apr;19(2):138-42. doi: 10.4103/0972-0707.178692.
PubMed 27099419Capar ID, Altunsoy M, Arslan H, Ertas H, Aydinbelge HA. Fracture strength of roots instrumented with self-adjusting file and the ProTaper rotary systems. J Endod. 2014 Apr;40(4):551-4. doi: 10.1016/j.joen.2013.08.030. Epub 2013 Oct 15.
PubMed 24666910Tavanafar S, Karimpour A, Karimpour H, Mohammed Saleh A, Hamed Saeed M. Effect of Different Instrumentation Techniques on Vertical Root Fracture Resistance of Endodontically Treated Teeth. J Dent (Shiraz). 2015 Mar;16(1 Suppl):50-5.
PubMed 26106635
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files
- ClinicalTrials.gov ID
- NCT05286073
- Acronym / sponsor ID
- IRB-1658/DUHS/Approval/2020/
- Keywords
- Hyflex EDM,F6 Sky Taper,One Shape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Mar 2022 (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 purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots.
Detailed description
88 human extracted mandibular premolars will be selected. Teeth will be sectioned below cementoenamel junction to get 13mm from the apex of root. Roots will then be standardized according to buccolingual and mesiodistal widths and will be examined for fracture and craze lines. The roots will then be randomly divided into 3 experimental groups and 1 control group (n=22). Group 1 will be instrumented with Hyflex EDM. Group 2 will be instrumented with F6 Sky Taper. Group 3 will be instrumented with One Shape and Group 4 will be negative control group in which no instrumentation will be done. After performing rotary instrumentation, roots will then be obturated with respective GP and sealer. Samples will then be exposed to vertical load utilizing Universal Testing Machine till fracture occur which will be recorded in Newton(N).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Samples were randomly divided in 4 groups. Random sampling was done with computer generated method. There were 3 working groups comprising of 22 canals and 1 negative control group having 22 canals.
| Arm | Type | Receives |
|---|---|---|
| Hyflex EDm | Experimental | Procedure: Endodontic Root Canal TreatmentThe canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm). |
| F6 SkyTaper | Experimental | Procedure: Endodontic Root Canal TreatmentThe canals were prepared and shaped with one file (25/~) and finished with 40/.04 using crown down technique. Torque controlled endodontic motor was used with a rotational speed of 500 rpm and torque of 2.5Ncm (25 Nm). |
| One Shape | Experimental | Procedure: Endodontic Root Canal TreatmentCanals were prepared and shaped with single rotational file system One Shape with the sequence of Endoflare (12, 0.12), One G (18, 0.03) and One Shape (12.06) connected to endodontic motor with rotational speed of 400rpm and 4 Ncm torque as recommended by manufacturer. |
| Control | No intervention | –In the control group, no endodontic instrumentation and shaping was done in the canals. Only the necrotic pulp tissue was extirpated from the canals with the help of barbed broaches and then the specimens were analyzed for fracture testing. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Extracted Human mandibular premolar canals that fulfill the following criteria were used.
Key exclusion criteria (9 listed)
- Roots having following features were excluded;
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 |
|---|---|---|
| Endodontic Root Canal TreatmentRoot canal shaping procedures were performed. Irrigation was done after each three pecks of endodontic file. After instrumentation (Groups 1-3), the canals were dried with sterile paper points. The dentinal walls were then coated with Sealapex. For vertical root fracture resistance testing, sample preparation was done in acrylic blocks. Then roots were coated with polyvinylsiloxane impression material. After that roots were inserted again into acrylic resin blocks. The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine. 0.5 mm diameter round tip stainless-steel rod was fixed to the universal testing machine. The universal testing machine was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, until the root fractured. The maximum amount of force necessary to fracture every sample was recorded in Newton (N). | Procedure or surgery | F6 SkyTaper, Hyflex EDm, One Shape |
Primary outcome
Vertical Root Fracture Resistance
Time frame: 5 minutes
The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine one at a time. 0.5 mm diameter round tip stainless-steel rod was fixed to the upper stage of the universal testing machine (Instron, Canton, MA, USA). The rod was centered over the canal orifice of each root. The universal testing machine (Instron) was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, at a rate of 1.0 mm per min, until the root fractured. This point was verified by the computer monitoring the Instron testing machine; at the same time the crack was heard, the monitor showed a sharp drop in force. The test was terminated at this point and the force applied was recorded. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
1 secondary outcome
Crack pattern
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 29628648Pawar AM, Pawar MG, Thakur B, Banga KS, Luke AM. Resistance to fracture of teeth instrumented using novel EndoStar E5 rotary versus ProTaper NEXT and WaveOne file systems. J Conserv Dent. 2018 Jan-Feb;21(1):52-56. doi: 10.4103/JCD.JCD_216_16.
- Background: PubMed 27099419Pawar AM, Barfiwala D, Pawar M, Metzger Z, Kfir A, Jain N. Assessment of the fracture resistance of teeth instrumented using 2 rotary and 2 reciprocating files versus the Self-Adjusting File (SAF): An ex vivo comparative study on mandibular premolars. J Conserv Dent. 2016 Mar-Apr;19(2):138-42. doi: 10.4103/0972-0707.178692.
- Background: PubMed 24666910Capar ID, Altunsoy M, Arslan H, Ertas H, Aydinbelge HA. Fracture strength of roots instrumented with self-adjusting file and the ProTaper rotary systems. J Endod. 2014 Apr;40(4):551-4. doi: 10.1016/j.joen.2013.08.030. Epub 2013 Oct 15.
- Background: PubMed 26106635Tavanafar S, Karimpour A, Karimpour H, Mohammed Saleh A, Hamed Saeed M. Effect of Different Instrumentation Techniques on Vertical Root Fracture Resistance of Endodontically Treated Teeth. J Dent (Shiraz). 2015 Mar;16(1 Suppl):50-5.
- Individual participant dataSharing planned: No
Related trials for Vertical Fracture of Root of Tooth (Disorder)
Not yet recruiting
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Mandibular Molars
Root Caries, Vertical Root Fracture
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.
Farah Naz, BDS,FCPS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic Root Canal Treatment in people with Vertical Fracture of Root of Tooth (Disorder), run by Dow University of Health Sciences at 1 site in Pakistan.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Mar 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Root Fracture Resistance (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286073, which also lists 4 linked publications.
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 18 Mar 2022.