Endodontic DiseaseNCT03641612
Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals
A study testing one shape and protaper next in people with Endodontic Disease, run by Heba Elasfouri at 1 site in Egypt.
Trial summary
Grouping: The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext Endodontics procedure steps: 1. Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively. 2. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- one shape and protaper next
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2018to 10 Nov 2018
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are medically free and good health.
- Patient 's age between 20-60years.
- Patients with posterior teeth diagnosed clinically and confirmed by thermal sensitivity tests as teeth with necrotic pulp.
- Positive patient's acceptance for participation in the study.
Who cannot join
- -Pregnancy or lactation
- Medically compromised patients -Patients aged less than20 or more than 60 years.-
- Patients unable to give informed consent.
- Previous endodontic therapy of the affected tooth .
- Teeth diagnosed with vital pulp.
- Teeth with periodontal pocket more than 3mm deep.
Show all 9Show fewer
- Teeth with abnormal anatomy and calcified canals.
- Teeth with caries below the bony level (non-restorable tooth).
- Teeth with periapical swelling or sinus tract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals (A Randomized Clinical Trial)
- Grouping: The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext
- Endodontics procedure steps:
- Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
- All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. 2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above. 2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator. 3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument. 4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone). 5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
Read the detailed description
Materials and Methods:
- Trial Design:
The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT). The clinical trial involves research using human participants. In this trial, the participants will be randomly allocated to receive one of two interventions according to the protocol created by the investigator; one of these interventions will be the control. The investigator is to determine the safety and/or the efficacy of the interventions after being received by the participants by measuring the outcomes because the outcomes will be measured, RCTs are quantitative studies.
- Grouping: The patients will be randomly assigned into two equal groups according to the type of rotary endodontic system used during root canal preparation: Group : OneShape Group : ProtaperNext
- Endodontics procedure steps:
- Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
- All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2 ( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. 2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above. 2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator. 3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument. 4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone). 5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique. 6- All procedures will be done in a single-visit, checked radiographically and recorded in the procedure chart.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
As a parameter for calculation of the amount of endotoxins in the root canal samples, a standard curve will be plotted by using the endotoxin of known concentration supplied by the kit according to the manufacturer's instructions.
The test procedure will be performed according to the manufacturer's instructions. And the absorbance of endotoxins will be measured by using spectrophotometer at wavelength 450 nm.
- Outcomes:
Evaluation of the antibacterial effect of using One Shape and Protaper Next rotary endodontic NiTi instruments for root canal preparation using Human endotoxin (ET) ELISA Kit
- Randomization:
The randomization will be done in three steps:
- Sequence generation: The random sequence generation will be done for the patients' numbers (from 1 to 38) using Microsoft Excel software. Allocation concealment mechanism: The allocation concealment will be phone-based.
- Implementation:
The random sequence will be done by a colleague and the random sequence table will be kept with him. After eligibility assessment, the operator would call the colleague for eligibility checking and to know the group assignment for the patients.
- Blinding:
Participants, outcome assessor and data analyst will be blinded in this trial. The operator will be not blinded.
- Conditions
- Endodontic Disease
- Being tested
- one shape, protaper next
- Keywords
- rotary instruments, endotoxins
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one shapeOther
canal fluid sample before and after root canal instrumentation
protaper nextOther
canal fluid sample before and after root canal instrumentation
| Study group | Role | What they receive |
|---|---|---|
| one shape | Experimental | single file rotary system Receives: Other: one shape |
| protaper next | Active comparator | multiple file rotary system Receives: Other: protaper next |
What is being measured
The primary outcome is the main question the study is designed to answer.
endotoxin change
Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
Measured: Samples will be collected before and after chemomechanical preparation over 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start10 Aug 2018
- Primary completion1 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heba Elasfouri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heba Elasfouri, Cairo University
- Investigators
- heba elasfouri, lecturer, Principal investigator, Cairo Universitymarwa bedier, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641612
- Sponsor's protocol ID
- CEBD-CU-2018-8-17
- Status last verified
- Jan 2019
- First submitted
- 16 Aug 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Root Canal Instruments on Removal of Endotoxins From Necrotic Root Canals (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03641612
- Acronym / sponsor ID
- CEBD-CU-2018-8-17
- Conditions
- Endodontic Disease
- Keywords
- rotary instruments, endotoxins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heba ElasfouriUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 22 Aug 2018 (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.
- Grouping: The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext
- Endodontics procedure steps:
- Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
- All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. 2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above. 2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator. 3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument. 4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone). 5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
Detailed description
Materials and Methods:
- Trial Design:
The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT). The clinical trial involves research using human participants. In this trial, the participants will be randomly allocated to receive one of two interventions according to the protocol created by the investigator; one of these interventions will be the control. The investigator is to determine the safety and/or the efficacy of the interventions after being received by the participants by measuring the outcomes because the outcomes will be measured, RCTs are quantitative studies.
- Grouping: The patients will be randomly assigned into two equal groups according to the type of rotary endodontic system used during root canal preparation: Group : OneShape Group : ProtaperNext
- Endodontics procedure steps:
- Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively.
- All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2 ( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. 2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above. 2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator. 3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument. 4-After root canal preparation, NaOCl will be inactivated with 5 mL of sterile 5% sodium thiosulphate for 1 minute, which then will be removed with 5 mL of sterile/apyrogenic saline solution., which then will be removed with 5 mL of sterile/apyrogenic saline solution. second endotoxin sample (S2) will be taken from the root canals. (5 paper point size of the master cone). 5- After completion of instrumentation and irrigation, obturation will be done using size 30/ 0.4 taper gutta-percha cones and auxiliaries as needed using the modified single cone technique. 6- All procedures will be done in a single-visit, checked radiographically and recorded in the procedure chart.
Determination of Endotoxin Concentration Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
As a parameter for calculation of the amount of endotoxins in the root canal samples, a standard curve will be plotted by using the endotoxin of known concentration supplied by the kit according to the manufacturer's instructions.
The test procedure will be performed according to the manufacturer's instructions. And the absorbance of endotoxins will be measured by using spectrophotometer at wavelength 450 nm.
- Outcomes:
Evaluation of the antibacterial effect of using One Shape and Protaper Next rotary endodontic NiTi instruments for root canal preparation using Human endotoxin (ET) ELISA Kit
- Randomization:
The randomization will be done in three steps:
- Sequence generation: The random sequence generation will be done for the patients' numbers (from 1 to 38) using Microsoft Excel software. Allocation concealment mechanism: The allocation concealment will be phone-based.
- Implementation:
The random sequence will be done by a colleague and the random sequence table will be kept with him. After eligibility assessment, the operator would call the colleague for eligibility checking and to know the group assignment for the patients.
- Blinding:
Participants, outcome assessor and data analyst will be blinded in this trial. The operator will be not blinded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial design of this study will be a prospective, parallel, Randomized clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| one shape | Experimental | Other: one shapesingle file rotary system |
| protaper next | Active comparator | Other: protaper nextmultiple file rotary system |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are medically free and good health.
- Patient 's age between 20-60years.
- Patients with posterior teeth diagnosed clinically and confirmed by thermal sensitivity tests as teeth with necrotic pulp.
- Positive patient's acceptance for participation in the study.
Key exclusion criteria (9 listed)
- -Pregnancy or lactation
- Medically compromised patients -Patients aged less than20 or more than 60 years.-
- Patients unable to give informed consent.
- Previous endodontic therapy of the affected tooth .
- Teeth diagnosed with vital pulp.
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 |
|---|---|---|
| one shapecanal fluid sample before and after root canal instrumentation | Other | one shape |
| protaper nextcanal fluid sample before and after root canal instrumentation | Other | protaper next |
Primary outcome
endotoxin change
Time frame: Samples will be collected before and after chemomechanical preparation over 2 months
Human endotoxin (ET) ELISA Kit will be used to measure endotoxin concentrations in the root canals before and after chemomechanical procedures.
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 Jan 2019.
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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.
heba elasfouri, lecturer principal investigator
Cairo University
marwa bedier, lecturer 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 one shape and protaper next in people with Endodontic Disease, run by Heba Elasfouri 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 4 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 31 Jan 2019. 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?
endotoxin change (time frame: Samples will be collected before and after chemomechanical preparation over 2 months). 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 31 Jan 2019.