Postoperative PainNCT04314908
"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
A study testing Apical enlargement, Apical enlargement + Sonic Activation Assisted Irrigation and Non Apical enlargement in people with Postoperative Pain and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital.
Trial summary
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Endodontically Treated Teeth
- What is being tested?
- Apical enlargement, Apical enlargement + Sonic Activation Assisted Irrigation and Non Apical enlargement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2020to 10 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
- Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
Show all 9Show fewer
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
Who cannot join
- -The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Read the detailed description
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. Postoperative pain will be recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. The local anesthetic will be applied before the treatment start. The routine retreatment procedure will be applied. Different final irrigation solutions will be applied in accordance to the manufacturers' instructions. At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth will be examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.
- Conditions
- Postoperative Pain, Endodontically Treated Teeth
- Being tested
- Apical enlargement, Apical enlargement + Sonic Activation Assisted Irrigation, Non Apical enlargement, Non Apical enlargement + Sonic Activation Assisted Irrigation
- Keywords
- Endodontics, Postoperative Pain, Visual Analogue Pain Scale
- Medical subject headings
- Pain, Postoperative, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical enlargementProcedure or surgery
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will be opened. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
Apical enlargement + Sonic Activation Assisted IrrigationProcedure or surgery
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
Non Apical enlargementProcedure or surgery
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
Non Apical enlargement + Sonic Activation Assisted IrrigationProcedure or surgery
The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Apical enlargement | Experimental | Routine retreatment procedure will be performed at working length according to the apex locator at point "0". Receives: Procedure: Apical enlargement |
| Apical enlargement + Sonic Activation Assisted Irrigation | Experimental | Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied. Receives: Procedure: Apical enlargement + Sonic Activation Assisted Irrigation |
| Non Apical enlargement | Experimental | Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point. Receives: Procedure: Non Apical enlargement |
| Non Apical enlargement + Sonic Activation Assisted Irrigation | Experimental | Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied. Receives: Procedure: Non Apical enlargement + Sonic Activation Assisted Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Measured: Baseline, 12, 24, 48, 72 hours and 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start10 Jun 2020 (estimated)
- Primary completion10 Oct 2020 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Model description
- Parallel Assignment The patients were assigned to 4 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keziban Olcay, DDS, Phd, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314908
- Sponsor's protocol ID
- 224
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04314908
- Acronym / sponsor ID
- 224
- Conditions
- Postoperative Pain, Endodontically Treated Teeth
- Keywords
- Endodontics, Postoperative Pain, Visual Analogue Pain Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2020 (estimated)
- Primary completion
- 10 Oct 2020 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Detailed description
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. Postoperative pain will be recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. The local anesthetic will be applied before the treatment start. The routine retreatment procedure will be applied. Different final irrigation solutions will be applied in accordance to the manufacturers' instructions. At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth will be examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment The patients were assigned to 4 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
| Arm | Type | Receives |
|---|---|---|
| Apical enlargement | Experimental | Procedure: Apical enlargementRoutine retreatment procedure will be performed at working length according to the apex locator at point "0". |
| Apical enlargement + Sonic Activation Assisted Irrigation | Experimental | Procedure: Apical enlargement + Sonic Activation Assisted IrrigationRoutine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied. |
| Non Apical enlargement | Experimental | Procedure: Non Apical enlargementRoutine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point. |
| Non Apical enlargement + Sonic Activation Assisted Irrigation | Experimental | Procedure: Non Apical enlargement + Sonic Activation Assisted IrrigationRoutine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
- Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
Key exclusion criteria (1 listed)
- -The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
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 |
|---|---|---|
| Apical enlargementThe teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will be opened. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary. | Procedure or surgery | Apical enlargement |
| Apical enlargement + Sonic Activation Assisted IrrigationThe teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary. | Procedure or surgery | Apical enlargement + Sonic Activation Assisted Irrigation |
| Non Apical enlargementThe teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary. | Procedure or surgery | Non Apical enlargement |
| Non Apical enlargement + Sonic Activation Assisted IrrigationThe teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary. | Procedure or surgery | Non Apical enlargement + Sonic Activation Assisted Irrigation |
Primary outcome
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Time frame: Baseline, 12, 24, 48, 72 hours and 1 week.
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
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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.
Keziban Olcay, DDS, Phd principal investigator
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Apical enlargement, Apical enlargement + Sonic Activation Assisted Irrigation and Non Apical enlargement in people with Postoperative Pain and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital.
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 9 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: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keziban Olcay, DDS, PhD (05423385708, kolcay@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS (time frame: Baseline, 12, 24, 48, 72 hours and 1 week.). 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 1 May 2020.