Postoperative PainEarly Phase 1NCT02905773
Postoperative Pain After the Removal of Root Canal Filling Material
A Early Phase 1 study testing root canal therapy and root canal retreatment in people with Postoperative Pain, run by TC Erciyes University.
Trial summary
The aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- root canal therapy and root canal retreatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2016
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- asymptomatic incisor teeth with chronic apical periodontitis
- patients between 18-55 years of age
Who cannot join
- patients with systemic disease
About this study
Official title: Postoperative Pain After the Removal of Root Canal Filling Material Using Different Techniques in Teeth With Failed Root Canal Therapy: A Randomized Clinical Trial
The aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques.
The patients were assigned to three groups of 45 patients, according to the method used to remove old canal filling material. The presence of postoperative pain was assessed after 6, 12, 24, 48, and 72 hours, 7 days, and finally after 10 days.
The hypothesis of this study: there would be no difference in postoperative pain intensity among the groups.
- Conditions
- Postoperative Pain
- Being tested
- root canal therapy, root canal retreatment
- Keywords
- Intensity
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal therapyOther
effect of devices ( ProTaper and Reciprocal Files)
root canal retreatmentOther
effect of devices ( ProTaper and Reciprocal Files)
| Study group | Role | What they receive |
|---|---|---|
| postoperative pain | Other | postoperative pain Receives: Other: root canal therapy |
| intensity | Other | intensity Receives: Other: root canal retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain after non-surgical endodontic retreatment using modified visual analog scale
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
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 TC Erciyes 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüseyin Sinan TOPÇUOĞLU, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905773
- Sponsor's protocol ID
- 232/2015
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After the Removal of Root Canal Filling Material Using Different Techniques in Teeth With Failed Root Canal Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02905773
- Acronym / sponsor ID
- 232/2015
- Conditions
- Postoperative Pain
- Keywords
- Intensity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Sep 2016 (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 aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques.
The patients were assigned to three groups of 45 patients, according to the method used to remove old canal filling material. The presence of postoperative pain was assessed after 6, 12, 24, 48, and 72 hours, 7 days, and finally after 10 days.
The hypothesis of this study: there would be no difference in postoperative pain intensity among the groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative pain | Other | Other: root canal therapypostoperative pain |
| intensity | Other | Other: root canal retreatmentintensity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- asymptomatic incisor teeth with chronic apical periodontitis
- patients between 18-55 years of age
Key exclusion criteria (1 listed)
- patients with systemic 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 |
|---|---|---|
| root canal therapyeffect of devices ( ProTaper and Reciprocal Files) | Other | postoperative pain |
| root canal retreatmenteffect of devices ( ProTaper and Reciprocal Files) | Other | intensity |
Primary outcome
postoperative pain after non-surgical endodontic retreatment using modified visual analog scale
Time frame: 10 days
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 20 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing root canal therapy and root canal retreatment in people with Postoperative Pain, run by TC Erciyes University.
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 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 20 Sep 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
postoperative pain after non-surgical endodontic retreatment using modified visual analog scale (time frame: 10 days). 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 20 Sep 2016.