Postoperative Pain After Dental Post Application

NCT03942107 | Completed

• 1 other identifier: dental posts postop pain
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Endodontically Treated Teeth; Vibration; Exposure

Keywords

Dental posts; postoperative pain; single-visit root canal treatment; two-visit root canal treatment; vibration

Outcome Measures

Primary Outcomes (1)

• 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.

  24, 48, and 72 hours; 7 days

Study Arms (2)

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.

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.

Procedure: Group 2: two-visit RCT

Interventions

Group 1: single-visit RCT PROCEDURE

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

Also known as: 1-visit RCT

Group 1: RCT+post+core in 1 visit

Group 2: two-visit RCT PROCEDURE

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.

Also known as: 2-visit RCT

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• TAN F EYUBOGLU, DDS,PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Head of Department of Endodontics

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: April 5, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

TU (1)