Foraminal Enlargement and Postoperative Pain.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02770053

Enrollment

Registered

2016-05-12

Start date

2016-01-31

Completion date

2016-05-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Postoperative

Keywords

Foraminal enlargement, Root canal treatment

Brief 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.

Detailed 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.

Interventions

PROCEDUREForaminal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
4-step pain intensity measures using a Visual Analog Scale (VAS).	7 days.	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.

Secondary

Measure	Time frame	Description
The number of patients taking an analgesic following the endodontics treatment.	7 days.	The patients were asked to take an analgesic in the 7 days of time frame.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026