Pain PostoperativePhase 1NCT02768285
Apical Patency and Postoperative Pain.
A Phase 1 study testing APICAL PATENCY in people with Pain Postoperative, run by Isparta Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior 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?
- APICAL PATENCY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 7 Aug 2017
- 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 permanent teeth having plural 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.
About this study
Official title: Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.
Read the detailed description
Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.
- Conditions
- Pain Postoperative
- Being tested
- APICAL PATENCY
- Keywords
- apical patency, 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.
APICAL PATENCYProcedure or surgery
After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Endodontic treatment was performed in posterior teeth with necrotic pulp and periapical periodontitis using a reciprocating single-file system (Reciproc). Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 2.5 % sodium hypochlorite, canal negotiation was done \& apical patency was achieved with #10 K-files in patency group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills was done. The canals were obturated with gutta-percha and epoxy resin sealer. The treatments were carried out in one-visit. Receives: Procedure: APICAL PATENCY |
| Control | No intervention | In the control group, apical patency did not maintained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-mm Visual Analog Scale (VAS).
Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm) and severe pain (75-100 mm).
Measured: 7 days.
Secondary outcomes (1)
The number of patients taking an analgesic following the endodontic 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 posted11 May 2016 (estimated)
- Study start1 Jan 2016
- Primary completion17 Jul 2017
- Study completion7 Aug 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim E YAYLALI, Ph.D., Principal investigator, Isparta Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768285
- Sponsor's protocol ID
- IAH-1
- Status last verified
- Jan 2016
- First submitted
- 5 May 2016
- Last updated
- 25 Oct 2017
- 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 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02768285
- Acronym / sponsor ID
- IAH-1
- Conditions
- Pain Postoperative
- Keywords
- apical patency, root canal treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Isparta Military HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 11 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 maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.
Detailed description
Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: APICAL PATENCYEndodontic treatment was performed in posterior teeth with necrotic pulp and periapical periodontitis using a reciprocating single-file system (Reciproc). Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 2.5 % sodium hypochlorite, canal negotiation was done \& apical patency was achieved with #10 K-files in patency group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills was done. The canals were obturated with gutta-percha and epoxy resin sealer. The treatments were carried out in one-visit. |
| Control | No intervention | –In the control group, apical patency did not maintained. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mature permanent teeth having plural 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 |
|---|---|---|
| APICAL PATENCYAfter determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL. | Procedure or surgery | Intervention |
Primary outcome
100-mm Visual Analog Scale (VAS).
Time frame: 7 days.
Pain severity was evaluated as 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 endodontic 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 25 Oct 2017.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APICAL PATENCY in people with Pain Postoperative, 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 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 25 Oct 2017. 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 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?
100-mm 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 25 Oct 2017.