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Completed

NCT Number: NCT02768285

Apical Patency and Postoperative Pain.

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.

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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

Primary location

Isparta Military Hospital

Isparta, 32010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

APICAL PATENCY

Procedure

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

Primary outcomes

  1. 100-mm Visual Analog Scale (VAS).

    Time frame: 7 days.

    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).

Secondary outcomes

  1. The number of patients taking an analgesic following the endodontic 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 Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Oct 25, 2017

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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