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Completed

NCT Number: NCT02770053

Foraminal Enlargement and Postoperative Pain.

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

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Key information

Conditions

Pain Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foraminal enlargement

Procedure

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.

Primary outcomes

  1. 4-step pain intensity measures using a Visual Analog Scale (VAS).

    Time frame: 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 outcomes

  1. The number of patients taking an analgesic following the endodontics treatment.

    Time frame: 7 days.

    The patients were asked to take an analgesic in the 7 days of time frame.

Sponsors and collaborators

Lead sponsor

Isparta Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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