Root Canal InfectionNCT04793308
Radicular Dentin Remaining, Risk of Perforation and Canal Transportation in Manual Versus Rotary Instrumentation in Primary Molars
A study testing Endodontic files in people with Root Canal Infection, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Root canal preparation techniques using manual instruments have found to be time-consuming and may lead to iatrogenic errors such as ledging, zipping, canal transportation, and apical blockage. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Endodontic files
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Mar 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Extracted Second primary molars. Extracted second primary molars with at least 2/3 of root remaining or with minimal apical resorption.
- Extracted second primary molars without visual perforation resorption.
Who cannot join
- Exfoliated second primary molars. If pre assessment radiograph for extracted second primary molars reveals internal or external root resorption.
- Extracted second primary molars with extreme root curvature.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo, 0022
About this study
Official title: Comparison of Radicular Dentin Remaining, Risk of Perforation and Canal Transportation Between Manual Versus Rotary Instrumentation in Root Canals of Extracted Second Primary Molars: In Vitro Study
Background: Root canal preparation techniques using manual instruments have found to be time-consuming and may lead to iatrogenic errors such as ledging, zipping, canal transportation, and apical blockage. To overcome this, much attention has been directed toward root canal preparation using nickel-titanium (NiTi)-rotary instruments. The flexibility and the instrument design of NiTi-rotary files allow it to closely follow the original root canal path. Aim: This in vitro study aims to compare the amount of dentin removal in primary molars instrumented with hand versus rotary files and the root canal transportation and risk of perforation using cone beam computed tomography (CBCT). Materials and Method: ( 20 ) extracted discarded mandibular second primary molars were selected to contribute in the study, having minimal apical resorption with presence of at least two-third remaining root structure with absence of visual perforating resorption. The teeth included in the study were stored in water or saline till the experimental time. The extracted primary molars were divided into two groups of the study: Group I was prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland) and Group II was prepared by manual instrumentation using K type files. All the root canals (n=40) were prepared up to size 35 using the step-back technique. The teeth were subjected to CBCT scans for the evaluation of thickness of radicular dentin remaining, risk of perforation and canal transportation before and after instrumentation in the two groups at three different locations (2, 4 and 7 mm from the apex) . Dentin removal was calculated by superimposing images using the InVivo 5.1 software. Data were statistically analyzed using independent samples t test.
Read the detailed description
Aim of the study:
To compare the shape \& diameter of root canals, risk of perforation and the canal transportation after using rotary versus manual instruments on root extracted second primary molars.
Methodology:
Extracted second primary molars will be collected from the dental clinics of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
The teeth are extracted either due to periodontal problems or because they are not restorable (beyond restoration) by the conventional coronal restorations or full coverage restorations in the case of root caries.
The teeth will be selected according to our inclusions and exclusion criteria. The teeth will be collected, sterilized and stored according to the Occupational Safety and Health Administration guidelines and regulations, ultrasonic scaler will be used to clean and remove soft tissue debris and calculus attached to the teeth.
Teeth will be divided into two groups:
Group (1); ((ProTaper Next, Rotary system). Group (2); K- files, Manual instruments. For cleaning and shaping of the canal system and mechanical preparation of root canal treatment.
Then shape of the canal (Canal transportation), canal diameter and risk of canal perforation will be compared in both groups.
Before and after preparation of the root canal, the shape of the canal will be assessed by using cone-beam computed tomography (CBCT) and diameter of the canal will be measured by using cone-beam computed tomography (CBCT).
- Conditions
- Root Canal Infection
- Being tested
- Endodontic files
- Keywords
- Deciduous teeth, pulpectomy, root canal preparation, canal transportation,, Cone Beam Computerized Tomography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic filesOther
Engine-driven nickel titanium Ni-Ti instruments
| Study group | Role | What they receive |
|---|---|---|
| Group (1); (ProTaper Next, Rotary system). | Experimental | Group I teeth were prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland) Receives: Other: Endodontic files |
| Group (2); K- files, Manual instruments. | Experimental | Group II root canals were prepared by manual instrumentation using K type files Mani, Japan). Receives: Other: Endodontic files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radicular dentin remaining
Assessment of dentin remaining by Cone Beam Computerized Tomography (CBCT)
Measured: 3 months
Transportation of Root Canal
Assessment of Root Canal Transportation by Cone Beam Computerized Tomography
Measured: 3 months
Secondary outcomes (1)
Risk of Perforation
By Cone Beam Computerized Tomography (CBCT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Dec 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Dr. Rania Abdallah Nasr, Cairo University
- Investigators
- Rania Nasr, Assoc. Prof., Principal investigator, Cairo UniversityHany Sadek, Assoc. Prof., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793308
- Sponsor's protocol ID
- 111120
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radicular Dentin Remaining, Risk of Perforation and Canal Transportation Between Manual Versus Rotary Instrumentation in Root Canals of Extracted Second Primary Molars: In Vitro Study
- ClinicalTrials.gov ID
- NCT04793308
- Acronym / sponsor ID
- 111120
- Conditions
- Root Canal Infection
- Keywords
- Deciduous teeth, pulpectomy, root canal preparation, canal transportation,, Cone Beam Computerized Tomography.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Mar 2021 (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: Root canal preparation techniques using manual instruments have found to be time-consuming and may lead to iatrogenic errors such as ledging, zipping, canal transportation, and apical blockage. To overcome this, much attention has been directed toward root canal preparation using nickel-titanium (NiTi)-rotary instruments. The flexibility and the instrument design of NiTi-rotary files allow it to closely follow the original root canal path. Aim: This in vitro study aims to compare the amount of dentin removal in primary molars instrumented with hand versus rotary files and the root canal transportation and risk of perforation using cone beam computed tomography (CBCT). Materials and Method: ( 20 ) extracted discarded mandibular second primary molars were selected to contribute in the study, having minimal apical resorption with presence of at least two-third remaining root structure with absence of visual perforating resorption. The teeth included in the study were stored in water or saline till the experimental time. The extracted primary molars were divided into two groups of the study: Group I was prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland) and Group II was prepared by manual instrumentation using K type files. All the root canals (n=40) were prepared up to size 35 using the step-back technique. The teeth were subjected to CBCT scans for the evaluation of thickness of radicular dentin remaining, risk of perforation and canal transportation before and after instrumentation in the two groups at three different locations (2, 4 and 7 mm from the apex) . Dentin removal was calculated by superimposing images using the InVivo 5.1 software. Data were statistically analyzed using independent samples t test.
Detailed description
Aim of the study:
To compare the shape \& diameter of root canals, risk of perforation and the canal transportation after using rotary versus manual instruments on root extracted second primary molars.
Methodology:
Extracted second primary molars will be collected from the dental clinics of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
The teeth are extracted either due to periodontal problems or because they are not restorable (beyond restoration) by the conventional coronal restorations or full coverage restorations in the case of root caries.
The teeth will be selected according to our inclusions and exclusion criteria. The teeth will be collected, sterilized and stored according to the Occupational Safety and Health Administration guidelines and regulations, ultrasonic scaler will be used to clean and remove soft tissue debris and calculus attached to the teeth.
Teeth will be divided into two groups:
Group (1); ((ProTaper Next, Rotary system). Group (2); K- files, Manual instruments. For cleaning and shaping of the canal system and mechanical preparation of root canal treatment.
Then shape of the canal (Canal transportation), canal diameter and risk of canal perforation will be compared in both groups.
Before and after preparation of the root canal, the shape of the canal will be assessed by using cone-beam computed tomography (CBCT) and diameter of the canal will be measured by using cone-beam computed tomography (CBCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1); (ProTaper Next, Rotary system). | Experimental | Other: Endodontic filesGroup I teeth were prepared with rotary instrumentation using ProTaper Next (Dentsply, Switzerland) |
| Group (2); K- files, Manual instruments. | Experimental | Other: Endodontic filesGroup II root canals were prepared by manual instrumentation using K type files Mani, Japan). |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Extracted Second primary molars. Extracted second primary molars with at least 2/3 of root remaining or with minimal apical resorption.
- Extracted second primary molars without visual perforation resorption.
Key exclusion criteria (2 listed)
- Exfoliated second primary molars. If pre assessment radiograph for extracted second primary molars reveals internal or external root resorption.
- Extracted second primary molars with extreme root curvature.
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 filesEngine-driven nickel titanium Ni-Ti instruments | Other | Group (1); (ProTaper Next, Rotary system)., Group (2); K- files, Manual instruments. |
Primary outcome
Radicular dentin remaining
Time frame: 3 months
Assessment of dentin remaining by Cone Beam Computerized Tomography (CBCT)
Transportation of Root Canal
Time frame: 3 months
Assessment of Root Canal Transportation by Cone Beam Computerized Tomography
1 secondary outcome
Risk of Perforation
Time frame: 3 months
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 11 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Rania Nasr, Assoc. Prof. principal investigator
Cairo University
Hany Sadek, Assoc. Prof. principal investigator
Cairo University
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 files in people with Root Canal Infection, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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 11 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 Egypt. 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?
Radicular dentin remaining (time frame: 3 months). The study lists 2 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 11 Mar 2021.