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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03942107
Other study ID # dental posts postop pain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2019
Est. completion date October 31, 2019

Study information

Verified date November 2019
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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,


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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
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.

Locations

Country Name City State
Turkey Istanbul Medipol University School of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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