Postoperative PainNCT03942107
Postoperative Pain After Dental Post Application
A study testing Group 1: single-visit RCT and Group 2: two-visit RCT in people with Postoperative Pain and Endodontically Treated Teeth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study the effect of dental post application on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal treatment will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Endodontically Treated Teeth, Vibration; Exposure
- What is being tested?
- Group 1: single-visit RCT and Group 2: two-visit RCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2019to 31 Oct 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with asymptomatic teeth which were in need of orthograde non-surgical root canal treatment with post application
Who cannot join
- Patients
- who were younger than 18 years old,
- who had contradictory medical history for root canal treatment,
- who used antibiotics 1 month prior and analgesics 1 week prior to the treatment,
- who could not abide the follow-up time Teeth
- that were symptomatic
Show all 12Show fewer
- with previous root canal treatment
- with present or suspected vertical root fracture
- with ≥ 4 mm periodontal pocket depth
- with apical lesions ≥ 5mm
- with damaged or resorbed apex
- that were in need of apical surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Official title: The Effect of Dental Post Application After Root Canal Treatment on Postoperative Pain in Asymptomatic Teeth.
In this study the effect of dental post application on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal treatment will be evaluated.
Read the detailed description
The aim of this clinical study is to evaluate the effect of dental post application on postoperative pain intensity level in patients with asymptomatic teeth after a single-appointment root canal treatment. A total of one hundred patients with asymptomatic teeth and with no contradictory medical history who are indicated for non-surgical root canal treatment and application of a dental post at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between April and December of 2019 will be included. All of the patients will be recruited from the Istanbul Medipol University Dental Clinics in Istanbul. the patients will be divided in two groups (n=50). Consent will be obtained from all study participants before the treatment. After the root canal treatments are completed in single-visit, in the first groups dental posts will be applied immediately at the same visit and patients will be appointed for pain assessment. In group 2 after the root canal treatment a temporary filling be applied in the access cavity and patients will be appointed for pain assessment. Dental posts will be applied after the pain assessment is completed at the end of 1 week. All treatments will be performed by one endodontist. Postoperative pain intensity will be assessed at 24, 48, and 72 h; 7 days; after the treatment. The teeth will be examined according to postoperative pain intensity levels,
- Being tested
- Group 1: single-visit RCT, Group 2: two-visit RCT
- Keywords
- Dental posts, postoperative pain, single-visit root canal treatment, two-visit root canal treatment, vibration
- Medical subject headings
- Pain, Postoperative, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: single-visit RCTProcedure or surgery
Also called 1-visit RCT
both root canal treatment and post and core restoration of the coronal part of the tooth is completed in single visit prior to postoperative pain evaluation at 24, 48 and 72-h and 7-day follow-up time
Group 2: two-visit RCTProcedure or surgery
Also called 2-visit RCT
after root canal treatment is completed, postoperative pain evaluation will be conducted in this group at 24, 48 and 72-h and 7-day follow-up time. post-core application will be completed at the seventh day after postoperative pain evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RCT+post+core in 1 visit | Active comparator | the root canal treatment will be completed with 2Shape NiTi system as well as post and core application in the same visit prior to postoperative pain evaluation. Receives: Procedure: Group 1: single-visit RCT |
| Group 2: after RCT, post and core in 2nd visit | Active comparator | after root canal treatment conducted with 2Shape NiTi system, the postoperative pain evaluation will be completed prior applying post and core for coronal restoration. Receives: Procedure: Group 2: two-visit RCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postoperative Pain after post and core application in root canal traeted teeth
The primary outcome measure of the study is to assess if the application of post and core to restore coronal part of root canal treated teeth may have an additive effect on postoperative pain intensity. Postoperative pain is recorded using vertical Visual Analog Scale (VAS) at 24, 48, and 72-h and 7-day follow-up time by one operator. Patients are asked to mark their pain level on a vertical line with the end points "No pain" and "Worst possible pain". The distance of the marked point to "no pain" end point is measured to calculated pain intensity level. The longer the distance the more the pain intensity level is.
Measured: 24, 48, and 72 hours; 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start5 Apr 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- after root canal treatment, post and core application in the first group and only root canal treatment in the second group post operative pain intensity will be assessed at 24, 48, and 72-h; 7-day follow-up.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Firat Eyuboglu, Istanbul Medipol University Hospital
- Investigators
- TAN F EYUBOGLU, DDS,PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942107
- Sponsor's protocol ID
- dental posts postop pain
- Status last verified
- Nov 2019
- First submitted
- 7 May 2019
- Last updated
- 14 Nov 2019
- 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 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dental Post Application After Root Canal Treatment on Postoperative Pain in Asymptomatic Teeth.
- ClinicalTrials.gov ID
- NCT03942107
- Acronym / sponsor ID
- dental posts postop pain
- Keywords
- Dental posts, postoperative pain, single-visit root canal treatment, two-visit root canal treatment, vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 8 May 2019 (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.
In this study the effect of dental post application on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal treatment will be evaluated.
Detailed description
The aim of this clinical study is to evaluate the effect of dental post application on postoperative pain intensity level in patients with asymptomatic teeth after a single-appointment root canal treatment. A total of one hundred patients with asymptomatic teeth and with no contradictory medical history who are indicated for non-surgical root canal treatment and application of a dental post at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between April and December of 2019 will be included. All of the patients will be recruited from the Istanbul Medipol University Dental Clinics in Istanbul. the patients will be divided in two groups (n=50). Consent will be obtained from all study participants before the treatment. After the root canal treatments are completed in single-visit, in the first groups dental posts will be applied immediately at the same visit and patients will be appointed for pain assessment. In group 2 after the root canal treatment a temporary filling be applied in the access cavity and patients will be appointed for pain assessment. Dental posts will be applied after the pain assessment is completed at the end of 1 week. All treatments will be performed by one endodontist. Postoperative pain intensity will be assessed at 24, 48, and 72 h; 7 days; after the treatment. The teeth will be examined according to postoperative pain intensity levels,
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- after root canal treatment, post and core application in the first group and only root canal treatment in the second group post operative pain intensity will be assessed at 24, 48, and 72-h; 7-day follow-up.
| Arm | Type | Receives |
|---|---|---|
| Group 1: RCT+post+core in 1 visit | Active comparator | Procedure: Group 1: single-visit RCTthe root canal treatment will be completed with 2Shape NiTi system as well as post and core application in the same visit prior to postoperative pain evaluation. |
| Group 2: after RCT, post and core in 2nd visit | Active comparator | Procedure: Group 2: two-visit RCTafter root canal treatment conducted with 2Shape NiTi system, the postoperative pain evaluation will be completed prior applying post and core for coronal restoration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with asymptomatic teeth which were in need of orthograde non-surgical root canal treatment with post application
Key exclusion criteria (12 listed)
- Patients
- who were younger than 18 years old,
- who had contradictory medical history for root canal treatment,
- who used antibiotics 1 month prior and analgesics 1 week prior to the treatment,
- who could not abide the follow-up time 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 |
|---|---|---|
| Group 1: single-visit RCTAlso: 1-visit RCTboth root canal treatment and post and core restoration of the coronal part of the tooth is completed in single visit prior to postoperative pain evaluation at 24, 48 and 72-h and 7-day follow-up time | Procedure or surgery | Group 1: RCT+post+core in 1 visit |
| Group 2: two-visit RCTAlso: 2-visit RCTafter root canal treatment is completed, postoperative pain evaluation will be conducted in this group at 24, 48 and 72-h and 7-day follow-up time. post-core application will be completed at the seventh day after postoperative pain evaluation. | Procedure or surgery | Group 2: after RCT, post and core in 2nd visit |
Primary outcome
Change from Baseline in Postoperative Pain after post and core application in root canal traeted teeth
Time frame: 24, 48, and 72 hours; 7 days
The primary outcome measure of the study is to assess if the application of post and core to restore coronal part of root canal treated teeth may have an additive effect on postoperative pain intensity. Postoperative pain is recorded using vertical Visual Analog Scale (VAS) at 24, 48, and 72-h and 7-day follow-up time by one operator. Patients are asked to mark their pain level on a vertical line with the end points "No pain" and "Worst possible pain". The distance of the marked point to "no pain" end point is measured to calculated pain intensity level. The longer the distance the more the pain intensity level is.
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 14 Nov 2019.
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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.
TAN F EYUBOGLU, 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 study testing Group 1: single-visit RCT and Group 2: two-visit RCT in people with Postoperative Pain and Endodontically Treated Teeth, 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 1 inclusion and 12 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 14 Nov 2019. 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?
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 post and core application in root canal traeted teeth (time frame: 24, 48, and 72 hours; 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 14 Nov 2019.