FE in Anterior Teeth

Pain, Postoperative Clinical Trial

Official title:

Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527602
• Other study ID #: IAH-5
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2017
• Est. completion date: August 5, 2018

Study information

• Verified date: June 2018
• Source: Isparta Military Hospital
• Contact: ibrahim Ethem Yaylali, PhD
• Phone: 05378707924
• Email: ibotenring[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with 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 in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 5, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Mature permenent maxillary anterior 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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

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

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).	The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)	5 days
Secondary	The number of patients taking an analgesic following the endodontics treatment.	The patients were asked to take an analgesic in the 5 days of time frame.	5 days