Postoperative PainPhase 4NCT03042377
Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases
A Phase 4 study testing Single-Visit Retreatment, Multiple-Visit-"Calcium Hydroxide" and Multiple-Visit-"Corticosteroid Paste" in people with Postoperative Pain and Root Canal Infection, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs. 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, Root Canal Infection, Endodontic Disease
- What is being tested?
- Single-Visit Retreatment, Multiple-Visit-"Calcium Hydroxide" and Multiple-Visit-"Corticosteroid Paste"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2015to 30 Aug 2015
- Phase
- Phase 4
- 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 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 months,
- have multiple teeth that required retreatment 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
1 site in 1 country.
About this study
Official title: The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.
Read the detailed description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was 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 was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.
- Conditions
- Postoperative Pain, Root Canal Infection, Endodontic Disease
- Being tested
- Single-Visit Retreatment, Multiple-Visit-"Calcium Hydroxide", Multiple-Visit-"Corticosteroid Paste", Multiple-Visit-"Antibiotic Paste"
- Keywords
- Endodontics, Retreatment, Postoperative Pain, Visual Analogue Pain Scale
- Medical subject headings
- Pain, Postoperative, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Visit RetreatmentOther
Also called Single-Visit Root Canal Therapy
The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.
Multiple-Visit-"Calcium Hydroxide"Drug
Also called Calcium Hydroxide
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.
Multiple-Visit-"Corticosteroid Paste"Drug
Also called Ledermix Paste
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid \& antibiotic paste and the cavity was filled with temporary restorative material.
Multiple-Visit-"Antibiotic Paste"Drug
Also called Triple Antibiotic Paste
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.
| Study group | Role | What they receive |
|---|---|---|
| Single-Visit Retreatment | Active comparator | Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments. Receives: Other: Single-Visit Retreatment |
| Multiple-Visit-"Calcium Hydroxide" | Active comparator | Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. Receives: Drug: Multiple-Visit-"Calcium Hydroxide" |
| Multiple-Visit-"Corticosteroid Paste" | Active comparator | Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. Receives: Drug: Multiple-Visit-"Corticosteroid Paste" |
| Multiple-Visit-"Antibiotic Paste" | Active comparator | Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. Receives: Drug: Multiple-Visit-"Antibiotic Paste" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postoperative Pain after Retreatment at 48 hours.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment 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 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the 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 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Measured: Baseline, 1, 6, 12, 24 and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2015
- Primary completion30 Jul 2015
- Study completion30 Aug 2015
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.
- More trials run by Istanbul Medipol University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keziban Olcay, Istanbul Medipol University Hospital
- Investigators
- Keziban Olcay, DDS. PhD., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042377
- Sponsor's protocol ID
- 156
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- 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 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03042377
- Acronym / sponsor ID
- 156
- Conditions
- Postoperative Pain, Root Canal Infection, Endodontic Disease
- Keywords
- Endodontics, Retreatment, Postoperative Pain, Visual Analogue Pain Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Aug 2015 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.
Detailed description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was 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 was 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
- Single blind (participant)
- Number of arms
- 4
- Model description
- The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
| Arm | Type | Receives |
|---|---|---|
| Single-Visit Retreatment | Active comparator | Other: Single-Visit RetreatmentRoot canal retreatment were performed according to the guidelines for single-visit endodontic treatments. |
| Multiple-Visit-"Calcium Hydroxide" | Active comparator | Drug: Multiple-Visit-"Calcium Hydroxide"Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. |
| Multiple-Visit-"Corticosteroid Paste" | Active comparator | Drug: Multiple-Visit-"Corticosteroid Paste"Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. |
| Multiple-Visit-"Antibiotic Paste" | Active comparator | Drug: Multiple-Visit-"Antibiotic Paste"Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments. |
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 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 |
|---|---|---|
| Single-Visit RetreatmentAlso: Single-Visit Root Canal TherapyThe teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary. | Other | Single-Visit Retreatment |
| Multiple-Visit-"Calcium Hydroxide"Also: Calcium HydroxideThe teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material. | Drug | Multiple-Visit-"Calcium Hydroxide" |
| Multiple-Visit-"Corticosteroid Paste"Also: Ledermix PasteThe teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid \& antibiotic paste and the cavity was filled with temporary restorative material. | Drug | Multiple-Visit-"Corticosteroid Paste" |
| Multiple-Visit-"Antibiotic Paste"Also: Triple Antibiotic PasteThe teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material. | Drug | Multiple-Visit-"Antibiotic Paste" |
Primary outcome
Change from Baseline in Postoperative Pain after Retreatment at 48 hours.
Time frame: Baseline, 1, 6, 12, 24 and 48 hours.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment 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 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the 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 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
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 1 Mar 2018.
- 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.
Keziban Olcay, DDS. PhD. principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single-Visit Retreatment, Multiple-Visit-"Calcium Hydroxide" and Multiple-Visit-"Corticosteroid Paste" in people with Postoperative Pain and Root Canal Infection, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 1 Mar 2018. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in Postoperative Pain after Retreatment at 48 hours. (time frame: Baseline, 1, 6, 12, 24 and 48 hours.). 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 Mar 2018.