Pain PostoperativePhase 1NCT02770053
Foraminal Enlargement and Postoperative Pain.
A Phase 1 study testing Foraminal enlargement in people with Pain Postoperative, run by Isparta Military Hospital.
Trial summary
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Postoperative
- What is being tested?
- Foraminal enlargement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mature permenent teeth having pulpal necrosis and apical periodontitis.
Who cannot join
- Systemic disorders
- Diabetes
- Pregnancy
- Less than 18 years of age
- Immunocompromised
- Patients who had taken antibiotics in the past 1 month
- Patients who had a positive history of analgesic use within the past 3 days
- Previously accessed teeth
About this study
Official title: Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.
Read the detailed description
Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.
- Conditions
- Pain Postoperative
- Being tested
- Foraminal enlargement
- Keywords
- Foraminal enlargement, Root canal treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foraminal enlargementProcedure or surgery
After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. Receives: Procedure: Foraminal enlargement |
| Control | Active comparator | In the control group, no foraminal enlargement will be performed. Receives: Procedure: Foraminal enlargement |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-step pain intensity measures using a Visual Analog Scale (VAS).
The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.
Measured: 7 days.
Secondary outcomes (1)
The number of patients taking an analgesic following the endodontics treatment.
The patients were asked to take an analgesic in the 7 days of time frame.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ethem YAYLALI, Isparta Military Hospital
- Investigators
- Ibrahim E YAYLALI, Ph.D., Principal investigator, Isparta Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770053
- Sponsor's protocol ID
- IAH-2
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02770053
- Acronym / sponsor ID
- IAH-2
- Conditions
- Pain Postoperative
- Keywords
- Foraminal enlargement, Root canal treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Isparta Military HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 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 purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.
Detailed description
Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Foraminal enlargementEndodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. |
| Control | Active comparator | Procedure: Foraminal enlargementIn the control group, no foraminal enlargement will be performed. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mature permenent teeth having pulpal necrosis and apical periodontitis.
Key exclusion criteria (8 listed)
- Systemic disorders
- Diabetes
- Pregnancy
- Less than 18 years of age
- Immunocompromised
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 |
|---|---|---|
| Foraminal enlargementAfter determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. | Procedure or surgery | Control, Intervention |
Primary outcome
4-step pain intensity measures using a Visual Analog Scale (VAS).
Time frame: 7 days.
The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.
1 secondary outcome
The number of patients taking an analgesic following the endodontics treatment.
Time frame: 7 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 31 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Ibrahim E YAYLALI, Ph.D. principal investigator
Isparta Military Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Foraminal enlargement in people with Pain Postoperative, run by Isparta Military 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 1 inclusion and 8 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 Oct 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
4-step pain intensity measures using a Visual Analog Scale (VAS). (time frame: 7 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 31 Oct 2016.