Foraminal Enlargement and Postoperative Pain.

Pain Postoperative Clinical Trial

Official title:

Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770053
• Other study ID #: IAH-2
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2016
• Last updated: October 28, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Isparta Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Description:

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Mature permenent teeth having pulpal 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Pain Postoperative
• Pain, Postoperative

Intervention

Procedure:
• Foraminal enlargement
After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isparta Military Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-step pain intensity measures using a Visual Analog Scale (VAS).	The severity of pain in 1-7 days according to the VAS: 0-3 mild pain, 4-7 moderate pain, and 8-10 severe pain.	7 days.	No
Secondary	The number of patients taking an analgesic following the endodontics treatment.	The patients were asked to take an analgesic in the 7 days of time frame.	7 days.	No