Pain, PostoperativeNCT03946306
Evaluation of Postoperative Pain With Eddy Tips (EPPET)
A study testing 5,25% NaOCl with syringe needle irrigation alone and EDDY in people with Pain, Postoperative, run by Universidade do Porto at 1 site in Portugal.
Trial summary
This investigation will focus on the use of EDDY tips, because it is known that the complete debridement of the canal is very difficult, which leads to an accumulation of tissue debris, bacteria and their products, resulting in persistent periradicular inflammation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 5,25% NaOCl with syringe needle irrigation alone and EDDY
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Feb 2020to 27 Feb 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
Who cannot join
- Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Medicina Dentária da Universidade do Porto
Porto, 4200-393
About this study
Official title: Comparative Evaluation of Postoperative Pain,Periapical Damage and Bacterial Disinfection After Using Endodontic Needle and Eddy Tips During Root Canal Irrigation
This investigation will focus on the use of EDDY tips, because it is known that the complete debridement of the canal is very difficult, which leads to an accumulation of tissue debris, bacteria and their products, resulting in persistent periradicular inflammation. So, it's of great importance, the study of other approaches of cleaning and disinfecting the root canal, which at the same time, may produce a lower risk of postoperative pain.
The above mentioned topics have never been analysed simultaneously with the use of EDDY tips, and the evaluation of the postoperative pain was never addressed.
Read more
This research is of great clinical interest, due to the complexity of root canal system, with isthmuses, ramifications and dentinal tubules, that make the total elimination of bacteria impossible, even with the best clinical protocols, because the irrigants cannot penetrate the dentinal tubules, and the postoperative pain is an exhausting factor for patients.
Therefore, a new protocol, with better disinfection rate and less postoperative pain, will be able to increase the success rate of endodontic treatments, allowing to save condemned teeth.
Read the detailed description
CLINICAL STUDY:
- Rate of postoperative pain of 2 endodontic disinfection protocols.
-A clinical study will be carried out, in patients that attend the Faculdade de Medicina Dentária Dental Clinic at Universidade do Porto, for initial nonsurgical root canal treatments. About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease. Those patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
All the patients will receive anaesthetic solution and after anaesthesia, each tooth will be isolated using rubber dam and the access cavity will be made.
The glide path will be determined using stainless steel hand files, confirmed by periapical radiographs. The root canals will be instrumented, confirming the apical patency with a size 15 K-file, and then the instrumentation sequence. The apical patency will be maintained throughout the shaping procedure using #10 k-file between each instrument.
- All the canals will be irrigated continuously with 5,25% NaOCl during the instrumentation, with a conventional endodontic syringe with 27 gauge needle. In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again. In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.
- After the final irrigation protocol, all the canals will be dried and sterile cotton pellets will be placed in the pulp chamber with a provisional restoration. No intracanal medicament will be placed. The obturation will be executed in the following appointment.
- Conditions
- Pain, Postoperative
- Being tested
- 5,25% NaOCl with syringe needle irrigation alone, EDDY
- Keywords
- ENDODONTIC IRRIGATION, ENDODONTIC DISINFECTION, EDDY TIPS, APICAL EXTRUSION, ENDODONTIC PAIN
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5,25% NaOCl with syringe needle irrigation aloneDrug
Also called NaOCl
In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again.
EDDYDevice
Also called EDDY + NaOCl
In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 5,25% NaOCl with syringe needle irrigation alone Receives: Drug: 5,25% NaOCl with syringe needle irrigation alone |
| Group 2 | Active comparator | 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany) Receives: Device: EDDY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative pain change during the first 48 hours after treatment
All patients will receive a paper with a visual analogue scale, to score their pain from 0 to 10. None of the patients will have analgesics prescribed immediately after the treatment. They will be advised to not take any medication at any point of the follow-up. If they need some advice or analgesic medication, they will be able to contact with the investigator.
The investigator will reach the patients after 8, 24 and 48 h, in order to ask their pain intensity and to ask if they need to take any analgesic to stop the pain. In case of any patient mentioning an important pain, it will be advised to take Ibuprofen 600mg every 6 hours, until the pain disappears. If any patient is allergic to non-steroidal anti-inflammatories, they will be advised to take paracetamol 1g and not take more than 4g per day. All the controls will be recorded on each patient's chart.
Measured: first 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start13 Feb 2020
- Primary completion10 Feb 2021
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cláudia Rodrigues, PhD, Study chair, Faculdade de Medicina Dentária da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946306
- Sponsor's protocol ID
- EDDYSP
- Other IDs
- 2019-001705-24, 2019
- Status last verified
- Oct 2020
- First submitted
- 23 Apr 2019
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Postoperative Pain,Periapical Damage and Bacterial Disinfection After Using Endodontic Needle and Eddy Tips During Root Canal Irrigation
- ClinicalTrials.gov ID
- NCT03946306
- Acronym / sponsor ID
- EDDYSP
- Conditions
- Pain, Postoperative
- Keywords
- ENDODONTIC IRRIGATION, ENDODONTIC DISINFECTION, EDDY TIPS, APICAL EXTRUSION, ENDODONTIC PAIN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 10 May 2019 (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.
This investigation will focus on the use of EDDY tips, because it is known that the complete debridement of the canal is very difficult, which leads to an accumulation of tissue debris, bacteria and their products, resulting in persistent periradicular inflammation. So, it's of great importance, the study of other approaches of cleaning and disinfecting the root canal, which at the same time, may produce a lower risk of postoperative pain.
The above mentioned topics have never been analysed simultaneously with the use of EDDY tips, and the evaluation of the postoperative pain was never addressed.
This research is of great clinical interest, due to the complexity of root canal system, with isthmuses, ramifications and dentinal tubules, that make the total elimination of bacteria impossible, even with the best clinical protocols, because the irrigants cannot penetrate the dentinal tubules, and the postoperative pain is an exhausting factor for patients.
Therefore, a new protocol, with better disinfection rate and less postoperative pain, will be able to increase the success rate of endodontic treatments, allowing to save condemned teeth.
Detailed description
CLINICAL STUDY:
- Rate of postoperative pain of 2 endodontic disinfection protocols.
-A clinical study will be carried out, in patients that attend the Faculdade de Medicina Dentária Dental Clinic at Universidade do Porto, for initial nonsurgical root canal treatments. About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease. Those patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
All the patients will receive anaesthetic solution and after anaesthesia, each tooth will be isolated using rubber dam and the access cavity will be made.
The glide path will be determined using stainless steel hand files, confirmed by periapical radiographs. The root canals will be instrumented, confirming the apical patency with a size 15 K-file, and then the instrumentation sequence. The apical patency will be maintained throughout the shaping procedure using #10 k-file between each instrument.
- All the canals will be irrigated continuously with 5,25% NaOCl during the instrumentation, with a conventional endodontic syringe with 27 gauge needle. In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again. In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.
- After the final irrigation protocol, all the canals will be dried and sterile cotton pellets will be placed in the pulp chamber with a provisional restoration. No intracanal medicament will be placed. The obturation will be executed in the following appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients will be divided in 2 groups: Group 1: (control group) 5,25% NaOCl with syringe needle irrigation alone. Group 2: 5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany)
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: 5,25% NaOCl with syringe needle irrigation alone5,25% NaOCl with syringe needle irrigation alone |
| Group 2 | Active comparator | Device: EDDY5,25% NaOCl with syringe needle irrigation, activated with sonic system EDDY (VDW, Munich, Germany) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- About 80 single-rooted and premolar teeth with mature, fully formed apices and diagnosed with irreversible pulpitis will be selected.
Key exclusion criteria (1 listed)
- Patients will be excluded if they were <12 years of age; pregnant; had an indication for antibiotic prophylaxis; uncontrolled hypertension or diabetes mellitus; chronic renal failure; hematologic diseases; HIV; osteoporosis treated with bisphosphonates; steroid therapy >5mg/day of prednisolone and prior to head and neck irradiation therapy. We will also exclude teeth with abnormal root canal anatomy, with more than 26mm in length and with advanced periodontal disease.
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 |
|---|---|---|
| 5,25% NaOCl with syringe needle irrigation aloneAlso: NaOClIn group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again. | Drug | Group 1 |
| EDDYAlso: EDDY + NaOClIn group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions. | Device | Group 2 |
Primary outcome
Evaluation of postoperative pain change during the first 48 hours after treatment
Time frame: first 48 hours after treatment
All patients will receive a paper with a visual analogue scale, to score their pain from 0 to 10. None of the patients will have analgesics prescribed immediately after the treatment. They will be advised to not take any medication at any point of the follow-up. If they need some advice or analgesic medication, they will be able to contact with the investigator. The investigator will reach the patients after 8, 24 and 48 h, in order to ask their pain intensity and to ask if they need to take any analgesic to stop the pain. In case of any patient mentioning an important pain, it will be advised to take Ibuprofen 600mg every 6 hours, until the pain disappears. If any patient is allergic to non-steroidal anti-inflammatories, they will be advised to take paracetamol 1g and not take more than 4g per day. All the controls will be recorded on each patient's chart.
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 7 Jun 2022.
- 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.
Cláudia Rodrigues, PhD study chair
Faculdade de Medicina Dentária da Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5,25% NaOCl with syringe needle irrigation alone and EDDY in people with Pain, Postoperative, run by Universidade do Porto at 1 site in Portugal.
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: finished, as of the sponsor's last update on 7 Jun 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 Portugal. 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?
Evaluation of postoperative pain change during the first 48 hours after treatment (time frame: first 48 hours after treatment). 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 7 Jun 2022.