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Postoperative Pain After Dental Post Application

Primary Purpose

Postoperative Pain, Endodontically Treated Teeth, Vibration; Exposure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1: single-visit RCT
Group 2: two-visit RCT
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Pain focused on measuring Dental posts, postoperative pain, single-visit root canal treatment, two-visit root canal treatment, vibration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: RCT+post+core in 1 visit

Group 2: after RCT, post and core in 2nd visit

Arm Description

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.

after root canal treatment conducted with 2Shape NiTi system, the postoperative pain evaluation will be completed prior applying post and core for coronal restoration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
November 13, 2019
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03942107
Brief Title
Postoperative Pain After Dental Post Application
Official Title
The Effect of Dental Post Application After Root Canal Treatment on Postoperative Pain in Asymptomatic Teeth.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Endodontically Treated Teeth, Vibration; Exposure
Keywords
Dental posts, postoperative pain, single-visit root canal treatment, two-visit root canal treatment, vibration

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: RCT+post+core in 1 visit
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: after RCT, post and core in 2nd visit
Arm Type
Active Comparator
Arm Description
after root canal treatment conducted with 2Shape NiTi system, the postoperative pain evaluation will be completed prior applying post and core for coronal restoration.
Intervention Type
Procedure
Intervention Name(s)
Group 1: single-visit RCT
Other Intervention Name(s)
1-visit RCT
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Group 2: two-visit RCT
Other Intervention Name(s)
2-visit RCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Postoperative Pain after post and core application in root canal traeted teeth
Description
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.
Time Frame
24, 48, and 72 hours; 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAN F EYUBOGLU, DDS,PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University School of Dentistry
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

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Postoperative Pain After Dental Post Application

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