Postoperative Pain After Dental Post Application

November 13, 2019 updated by: Tan Firat Eyuboglu, Istanbul Medipol University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Istanbul Medipol University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with asymptomatic teeth which were in need of orthograde non-surgical root canal treatment with post application

Exclusion Criteria:

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: RCT+post+core in 1 visit
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.
Procedure: Group 1: single-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
Other Names:
  • 1-visit RCT
Active Comparator: Group 2: after RCT, post and core in 2nd visit
after root canal treatment conducted with 2Shape NiTi system, the postoperative pain evaluation will be completed prior applying post and core for coronal restoration.
Procedure: Group 2: two-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.
Other Names:
  • 2-visit RCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24, 48, and 72 hours; 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: TAN F EYUBOGLU, DDS,PhD, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dental posts postop pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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