Periapical DiseasesNCT06752837
Comparing Efficacy of a Stainless-steel Rotary File with Two Nickel-titanium Systems on Periapical Lesion Healing
A study testing Tornado rotary system, WaveOne rotary system and OneShape rotary system in people with Periapical Diseases and Root Canal Infection, run by Beirut Arab University at 2 sites in Lebanon.
Trial summary
Background: This study used cone-beam computed tomography (CBCT) to compare a stainless-steel Tornado file system with OneShape and WaveOne rotary systems for biomechanical canal preparation as indicated by the healing of periapical lesions. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Periapical Diseases, Root Canal Infection
- What is being tested?
- Tornado rotary system, WaveOne rotary system and OneShape rotary system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesLebanon
- Study dates
- 6 Apr 2018to 9 Jan 2023
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients should have lower molars with
- Two separate mesial canals.
- Distinct apical foramen.
- Mature periapical apices.
- No tooth cracks.
- No root resorption.
- Canal curvature for mesial canals ranged from 15° to 45°.
Who cannot join
- Patient who is younger than 16 or older than 65.
- Diabetic patient.
- Immune-compromising conditions.
- Patient has previous dental work on the working tooth.
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites
College of dentistry, Beirut Arab University
Beirut
faculty of dentistry, Beirut Arab University
Beirut
About this study
Official title: Comparing the Efficacy of a Stainless-Steel Rotary File with Two Nickel-Titanium Systems on Periapical Lesion Healing Using Cone-Beam Computed Tomography
Background: This study used cone-beam computed tomography (CBCT) to compare a stainless-steel Tornado file system with OneShape and WaveOne rotary systems for biomechanical canal preparation as indicated by the healing of periapical lesions.
Methods: Lower molars with necrotic pulps and periapical lesions were arbitrarily divided into three groups (n=20) rendering to three rotary file systems. After root canal treatment, clinical and radiographic assessment of the apical radiolucency was evaluated at one year using pre- and post-instrumentation CBCT images. Statistical analysis was performed to compare the three systems at a p-value of 0.05.
Read the detailed description
A sample size of 60 subjects (38 females and 22 males) was randomly selected for this randomized clinical research based on a power of 80%, and a significance level of 0.05. The patients should have lower molars with two separate mesial canals, distinct apical foramen, mature apices, and neither cracks nor resorption. Canal curvature for mesial canals ranged from 15° to 45°. The study excluded patients younger than 16 or older than 65, who had diabetes, immune-compromising conditions, or had previous dental work on the working tooth. We informed the patients about the potential risks, discomfort, and potential benefits. Patients who met the inclusion criteria signed a consent form. Table 1 shows the demographics of the study samples. Every patient was evaluated and reviewed through appropriate history taking, clinical examinations, and pre-operative digital radiography. The past dental and medical history, major complaints, and demographic data were recorded. Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size. The patients were then divided randomly into three equal groups (n = 20). After proper anesthesia and isolation, access cavities were completed with a round bur, followed by an Endo Z bur. Working length was determined using an apex locator (DENTA PORT ZX, Japan), and confirmed by periapical X-ray. Canal patency was established with a #15 K-type file (MANI, Vietnam) and RC prep glide path (Premier Dental, USA). Canals were prepared with the assigned instrumentation system according to the manufacturer's instructions and irrigated with 2 mm of a 2.5% sodium hypochlorite solution (NaOCl) (Clorox, Lebanon) followed by 3.0 mL of 17% ethylene-diamine-tetraacetic acid (EDTA) (NEXABIO, Korea) for 1 minute, and then 1.3% NaOCl as final irrigation. Tornado Finisher was used as directed by the manufacturer at 1 mm short of the working length in an up-and-down motion. In the other two groups, irrigation was performed with a 31G side-vented needle (Ultradent Products Inc.) placed passively into the canal, 1 mm short of the working length.Intracanal calcium hydroxide was added to the canals for one week. Every tooth in the three groups underwent the same obturation procedure (Lateral condensation technique) using gutta-percha (DiaDent, Korea) and sealer (META BIOMED, Korea). Finally, coronal preparation of all teeth was restored with composite filling (Ivoclar, Switzerland). Clinical evaluation was conducted at a one-year follow-up visit for each patient including spontaneous pain, sinus tract, swelling, mobility, periodontal probing depths greater than baseline, or sensitivity to percussion or palpation. A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al.CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension . Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement. Cortical bone expansion (E) and cortical bone destruction (D) were included in the scoring system as appropriate. If either of these conditions was found in the CBCT analysis, the variables E and D were added to each score. Qualitative analysis of clinical evaluations was conducted for signs and symptoms. The pre- and post-operative Estrela et al. index scores were recorded. The Statistical Package for the Social Sciences software (SPSS 22, SPSS Inc, Chicago, IL) was used to perform the statistical analysis. The median was used to describe the qualitative data for all groups and normal distribution was tested using Shapiro-Wilk test. Since the data did not follow a normal distribution, the scores of the size of the apical lesion before and after one year were done for each group using the Wilcoxon signed ranks test while inter-group comparison was done using the Kruskal Wallis test followed by Mann-Whitney test for comparison of pairs. All statistical tests were performed at a p-value of 0.05.
- Conditions
- Periapical Diseases, Root Canal Infection
- Being tested
- Tornado rotary system, WaveOne rotary system, OneShape rotary system, Cone beam computed tomography
- Keywords
- CBCT, Nickel-titanium files, Tornado rotary system
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornado rotary systemDevice
Also called Revolving SS Tornado rotary system (MIB, FRANCE) in arm one
In arm one, stainless steel tornado files works by high-speed rotation that influences the fluid dynamics within the canal and improves irrigation efficiency. Canals are finished with a file having a 4% taper and an apical diameter of 0.25 mm.
WaveOne rotary systemDevice
Also called In arm two, WaveOne single reciprocating file system
In arm two, WaveOne system is a single reciprocating file system with a heat-treated NiTi Memory Wire (M Wire).It has a taper of 0.08 in apical 3 mm, with a tip diameter of 0.25 mm. in a torque control endodontic handpiece (X smart plus with reciprocation mode)
OneShape rotary systemDevice
Also called In arm three, OneShape rotary system
In arm three, OneShape system utilizes a conventional, continuous rotational motion. It has asymmetric cross-sectional geometry, and traveling waves of motion that are produced along the file's active region. It has a single constant taper of 0.06 and a tip size of 25 with distinct cross-sectional designs along the whole length of the working parts
Cone beam computed tomographyDevice
Also called Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size.
A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion.
| Study group | Role | What they receive |
|---|---|---|
| The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE). | Experimental | Root canal treatment was done using Stainless steel tornado rotary system Receives: Device: Tornado rotary system; Device: Cone beam computed tomography |
| Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues, | Experimental | Root canal treatment was done using WaveOne rotary system Receives: Device: WaveOne rotary system; Device: Cone beam computed tomography |
| The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France). | Experimental | Root canal treatment was done using OneShape rotary system Receives: Device: OneShape rotary system; Device: Cone beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimension lenght in millimeter for apical radiolucency in CBCT for each pateint
A post-operative Cone beam computed tomography(CBCT) image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in millimeters for the three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension. Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement.
Measured: One-year follow-up visit for each pateint
Secondary outcomes (1)
Qualitative scoring for clinical criteria for each pateint
The scoring description was collected for clinical criteria. The scoring was for the presence or absence of spontaneous pain, sinus tract, swelling, tooth mobility, sensitivity to percussion or palpation and the depth of periodontal probing in millimeter greater than preoperative baseline. Scoring was done for each item using scales according to published previous research in the literature.
Measured: One-year follow-up visit for each pateint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start6 Apr 2018
- Primary completion8 Mar 2022
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periapical DiseasesStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- alaa eldeen O Mais, PhD, Principal investigator, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752837
- Sponsor's protocol ID
- 2017-H-0056-D-P-0457
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD can't be shared due to ethical issues. IPD of this study is confidential.
Publications
Dorasani G, Madhusudhana K, Chinni SK. Clinical and radiographic evaluation of single-visit and multi-visit endodontic treatment of teeth with periapical pathology: An in vivo study. J Conserv Dent. 2013 Nov;16(6):484-8. doi: 10.4103/0972-0707.120933.
PubMed 24347878De-Deus G, Souza EM, Barino B, Maia J, Zamolyi RQ, Reis C, Kfir A. The self-adjusting file optimizes debridement quality in oval-shaped root canals. J Endod. 2011 May;37(5):701-5. doi: 10.1016/j.joen.2011.02.001. Epub 2011 Mar 23.
PubMed 21496675Patel S, Brown J, Pimentel T, Kelly RD, Abella F, Durack C. Cone beam computed tomography in Endodontics - a review of the literature. Int Endod J. 2019 Aug;52(8):1138-1152. doi: 10.1111/iej.13115. Epub 2019 Apr 9.
PubMed 30868610Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pecora JD. A new periapical index based on cone beam computed tomography. J Endod. 2008 Nov;34(11):1325-1331. doi: 10.1016/j.joen.2008.08.013. Epub 2008 Sep 17.
PubMed 18928840Moreinos D, Dakar A, Stone NJ, Moshonov J. Evaluation of Time to Fracture and Vertical Forces Applied by a Novel Gentlefile System for Root Canal Preparation in Simulated Root Canals. J Endod. 2016 Mar;42(3):505-8. doi: 10.1016/j.joen.2015.12.023. Epub 2016 Jan 28.
PubMed 26831050Mais AO, Abdallah AM, Osman E, Alhadainy HA. Cone-Beam Computed Tomographic Evaluation of Periapical Lesion Healing After Root Canal Preparation with Different File Systems. Bioengineering (Basel). 2025 Nov 19;12(11):1267. doi: 10.3390/bioengineering12111267.
PubMed 41301223
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of a Stainless-Steel Rotary File with Two Nickel-Titanium Systems on Periapical Lesion Healing Using Cone-Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT06752837
- Acronym / sponsor ID
- 2017-H-0056-D-P-0457
- Conditions
- Periapical Diseases, Root Canal Infection
- Keywords
- CBCT, Nickel-titanium files, Tornado rotary system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 31 Dec 2024 (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.
Background: This study used cone-beam computed tomography (CBCT) to compare a stainless-steel Tornado file system with OneShape and WaveOne rotary systems for biomechanical canal preparation as indicated by the healing of periapical lesions.
Methods: Lower molars with necrotic pulps and periapical lesions were arbitrarily divided into three groups (n=20) rendering to three rotary file systems. After root canal treatment, clinical and radiographic assessment of the apical radiolucency was evaluated at one year using pre- and post-instrumentation CBCT images. Statistical analysis was performed to compare the three systems at a p-value of 0.05.
Detailed description
A sample size of 60 subjects (38 females and 22 males) was randomly selected for this randomized clinical research based on a power of 80%, and a significance level of 0.05. The patients should have lower molars with two separate mesial canals, distinct apical foramen, mature apices, and neither cracks nor resorption. Canal curvature for mesial canals ranged from 15° to 45°. The study excluded patients younger than 16 or older than 65, who had diabetes, immune-compromising conditions, or had previous dental work on the working tooth. We informed the patients about the potential risks, discomfort, and potential benefits. Patients who met the inclusion criteria signed a consent form. Table 1 shows the demographics of the study samples. Every patient was evaluated and reviewed through appropriate history taking, clinical examinations, and pre-operative digital radiography. The past dental and medical history, major complaints, and demographic data were recorded. Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size. The patients were then divided randomly into three equal groups (n = 20). After proper anesthesia and isolation, access cavities were completed with a round bur, followed by an Endo Z bur. Working length was determined using an apex locator (DENTA PORT ZX, Japan), and confirmed by periapical X-ray. Canal patency was established with a #15 K-type file (MANI, Vietnam) and RC prep glide path (Premier Dental, USA). Canals were prepared with the assigned instrumentation system according to the manufacturer's instructions and irrigated with 2 mm of a 2.5% sodium hypochlorite solution (NaOCl) (Clorox, Lebanon) followed by 3.0 mL of 17% ethylene-diamine-tetraacetic acid (EDTA) (NEXABIO, Korea) for 1 minute, and then 1.3% NaOCl as final irrigation. Tornado Finisher was used as directed by the manufacturer at 1 mm short of the working length in an up-and-down motion. In the other two groups, irrigation was performed with a 31G side-vented needle (Ultradent Products Inc.) placed passively into the canal, 1 mm short of the working length.Intracanal calcium hydroxide was added to the canals for one week. Every tooth in the three groups underwent the same obturation procedure (Lateral condensation technique) using gutta-percha (DiaDent, Korea) and sealer (META BIOMED, Korea). Finally, coronal preparation of all teeth was restored with composite filling (Ivoclar, Switzerland). Clinical evaluation was conducted at a one-year follow-up visit for each patient including spontaneous pain, sinus tract, swelling, mobility, periodontal probing depths greater than baseline, or sensitivity to percussion or palpation. A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al.CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension . Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement. Cortical bone expansion (E) and cortical bone destruction (D) were included in the scoring system as appropriate. If either of these conditions was found in the CBCT analysis, the variables E and D were added to each score. Qualitative analysis of clinical evaluations was conducted for signs and symptoms. The pre- and post-operative Estrela et al. index scores were recorded. The Statistical Package for the Social Sciences software (SPSS 22, SPSS Inc, Chicago, IL) was used to perform the statistical analysis. The median was used to describe the qualitative data for all groups and normal distribution was tested using Shapiro-Wilk test. Since the data did not follow a normal distribution, the scores of the size of the apical lesion before and after one year were done for each group using the Wilcoxon signed ranks test while inter-group comparison was done using the Kruskal Wallis test followed by Mann-Whitney test for comparison of pairs. All statistical tests were performed at a p-value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE). | Experimental | Device: Tornado rotary system, Device: Cone beam computed tomographyRoot canal treatment was done using Stainless steel tornado rotary system |
| Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues, | Experimental | Device: WaveOne rotary system, Device: Cone beam computed tomographyRoot canal treatment was done using WaveOne rotary system |
| The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France). | Experimental | Device: OneShape rotary system, Device: Cone beam computed tomographyRoot canal treatment was done using OneShape rotary system |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The patients should have lower molars with
- Two separate mesial canals.
- Distinct apical foramen.
- Mature periapical apices.
- No tooth cracks.
Key exclusion criteria (4 listed)
- Patient who is younger than 16 or older than 65.
- Diabetic patient.
- Immune-compromising conditions.
- Patient has previous dental work on the working tooth.
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 |
|---|---|---|
| Tornado rotary systemAlso: Revolving SS Tornado rotary system (MIB, FRANCE) in arm oneIn arm one, stainless steel tornado files works by high-speed rotation that influences the fluid dynamics within the canal and improves irrigation efficiency. Canals are finished with a file having a 4% taper and an apical diameter of 0.25 mm. | Device | The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE). |
| WaveOne rotary systemAlso: In arm two, WaveOne single reciprocating file systemIn arm two, WaveOne system is a single reciprocating file system with a heat-treated NiTi Memory Wire (M Wire).It has a taper of 0.08 in apical 3 mm, with a tip diameter of 0.25 mm. in a torque control endodontic handpiece (X smart plus with reciprocation mode) | Device | Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues, |
| OneShape rotary systemAlso: In arm three, OneShape rotary systemIn arm three, OneShape system utilizes a conventional, continuous rotational motion. It has asymmetric cross-sectional geometry, and traveling waves of motion that are produced along the file's active region. It has a single constant taper of 0.06 and a tip size of 25 with distinct cross-sectional designs along the whole length of the working parts | Device | The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France). |
| Cone beam computed tomographyAlso: Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size.A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion. | Device | Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues,, The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE)., The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France). |
Primary outcome
Three-dimension lenght in millimeter for apical radiolucency in CBCT for each pateint
Time frame: One-year follow-up visit for each pateint
A post-operative Cone beam computed tomography(CBCT) image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in millimeters for the three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension. Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement.
1 secondary outcome
Qualitative scoring for clinical criteria for each pateint
Time frame: One-year follow-up visit for each pateint.
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 31 Dec 2024.
- Background: PubMed 24347878Dorasani G, Madhusudhana K, Chinni SK. Clinical and radiographic evaluation of single-visit and multi-visit endodontic treatment of teeth with periapical pathology: An in vivo study. J Conserv Dent. 2013 Nov;16(6):484-8. doi: 10.4103/0972-0707.120933.
- Background: PubMed 21496675De-Deus G, Souza EM, Barino B, Maia J, Zamolyi RQ, Reis C, Kfir A. The self-adjusting file optimizes debridement quality in oval-shaped root canals. J Endod. 2011 May;37(5):701-5. doi: 10.1016/j.joen.2011.02.001. Epub 2011 Mar 23.
- Background: PubMed 30868610Patel S, Brown J, Pimentel T, Kelly RD, Abella F, Durack C. Cone beam computed tomography in Endodontics - a review of the literature. Int Endod J. 2019 Aug;52(8):1138-1152. doi: 10.1111/iej.13115. Epub 2019 Apr 9.
- Background: PubMed 18928840Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pecora JD. A new periapical index based on cone beam computed tomography. J Endod. 2008 Nov;34(11):1325-1331. doi: 10.1016/j.joen.2008.08.013. Epub 2008 Sep 17.
- Background: PubMed 26831050Moreinos D, Dakar A, Stone NJ, Moshonov J. Evaluation of Time to Fracture and Vertical Forces Applied by a Novel Gentlefile System for Root Canal Preparation in Simulated Root Canals. J Endod. 2016 Mar;42(3):505-8. doi: 10.1016/j.joen.2015.12.023. Epub 2016 Jan 28.
- Derived from this study: PubMed 41301223Mais AO, Abdallah AM, Osman E, Alhadainy HA. Cone-Beam Computed Tomographic Evaluation of Periapical Lesion Healing After Root Canal Preparation with Different File Systems. Bioengineering (Basel). 2025 Nov 19;12(11):1267. doi: 10.3390/bioengineering12111267.
- Individual participant dataSharing planned: No. IPD can't be shared due to ethical issues. IPD of this study is confidential.
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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.
alaa eldeen O Mais, PhD principal investigator
Beirut Arab University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tornado rotary system, WaveOne rotary system and OneShape rotary system in people with Periapical Diseases and Root Canal Infection, run by Beirut Arab University at 2 sites in Lebanon.
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 7 inclusion and 4 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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?
Three-dimension lenght in millimeter for apical radiolucency in CBCT for each pateint (time frame: One-year follow-up visit for each pateint). 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 NCT06752837, which also lists 6 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 31 Dec 2024.