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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02768285
Other study ID # IAH-1
Secondary ID
Status Completed
Phase Phase 1
First received May 5, 2016
Last updated October 23, 2017
Start date January 1, 2016
Est. completion date August 7, 2017

Study information

Verified date January 2016
Source Isparta Military Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.


Description:

Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date August 7, 2017
Est. primary completion date July 17, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria:

- Mature permanent teeth having plural necrosis and apical periodontitis

Exclusion Criteria:

- Systemic disorders

- Diabetes

- Pregnancy

- Less than 18 years of age

- Immunocompromised

- Patients who had taken antibiotics in the past 1 month

- Patients who had a positive history of analgesic use within the past 3 days

- Previously accessed teeth

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
APICAL PATENCY
After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.

Locations

Country Name City State
Turkey Isparta Military Hospital Isparta

Sponsors (1)

Lead Sponsor Collaborator
Isparta Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 100-mm Visual Analog Scale (VAS). Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm) and severe pain (75-100 mm). 7 days.
Secondary The number of patients taking an analgesic following the endodontic treatment. The patients were asked to take an analgesic in the 7 days of time frame. 7 days.
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