Pain, PostoperativeNCT03527602
FE in Anterior Teeth
A study testing Foraminal enlargement in people with Pain, Postoperative and Apical Periodontitis, run by Isparta Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Apical Periodontitis
- 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2017to 5 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mature permenent maxillary anterior 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Isparta Military Hospital
Isparta, 32010
Ibrahim E YAYLALI, Ph.D., ibotenring@yahoo.com
About this study
Official title: Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with 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 in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.
- Conditions
- Pain, Postoperative, Apical Periodontitis
- Being tested
- Foraminal enlargement
- Keywords
- Apical patency, Endodontics
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis
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 rotary 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 maxillary anterior 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 rotary 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 | No intervention | In the control group, no foraminal enlargement will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-mm Visual Analog Scale (VAS).
The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: 5 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 5 days of time frame.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start5 Nov 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion5 Aug 2018 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
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 ethem yaylali, Principal investigator, Military Hospital, Isparta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527602
- Sponsor's protocol ID
- IAH-5
- Status last verified
- Jun 2018
- First submitted
- 3 May 2018
- Last updated
- 6 Jul 2018
- 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 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.
- ClinicalTrials.gov ID
- NCT03527602
- Acronym / sponsor ID
- IAH-5
- Conditions
- Pain, Postoperative, Apical Periodontitis
- Keywords
- Apical patency, Endodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Isparta Military HospitalUniversity, hospital or other
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 5 Aug 2018 (estimated)
- First posted
- 17 May 2018 (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 study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with 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 in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.
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 maxillary anterior 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 rotary 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 | No intervention | –In the control group, no foraminal enlargement will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.
Key exclusion criteria (1 listed)
- 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.
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 rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. | Procedure or surgery | Intervention |
Primary outcome
100-mm Visual Analog Scale (VAS).
Time frame: 5 days
The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
1 secondary outcome
The number of patients taking an analgesic following the endodontics treatment.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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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 ethem yaylali principal investigator
Military Hospital, Isparta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foraminal enlargement in people with Pain, Postoperative and Apical Periodontitis, run by Isparta Military 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 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: status not confirmed, as of the sponsor's last update on 6 Jul 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.
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 ibrahim Ethem Yaylali, PhD (05378707924, ibotenring@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100-mm Visual Analog Scale (VAS). (time frame: 5 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 6 Jul 2018.