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Completed

NCT Number: NCT03042377

Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases

The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.

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Key information

Conditions

Postoperative Pain Dental Pulp Diseases Endodontic Disease Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Root Canal Infection Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul Medipol University

Istanbul, 34083, Turkey (Türkiye)

About this study

The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients who were not included the study who;

  • were pregnant or breast feeding during the duration of the study,
  • have systemic disease,
  • have any pain and/or any facial swelling, abscess,
  • were immunocompromised,
  • were under 18 yrs. and over 65 yrs. age,
  • were taking antibiotics or corticosteroids within previous three months,
  • have multiple teeth that required retreatment at the same time period; for eliminating pain referral,
  • have root canals that could not be well-treated with orthograde retreatment.

Exclusion criteria

The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.

Treatment and study plan

Single-Visit Retreatment

Other

The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.

Other names: Single-Visit Root Canal Therapy

Multiple-Visit-"Calcium Hydroxide"

Drug

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.

Other names: Calcium Hydroxide

Multiple-Visit-"Corticosteroid Paste"

Drug

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid & antibiotic paste and the cavity was filled with temporary restorative material.

Other names: Ledermix Paste

Multiple-Visit-"Antibiotic Paste"

Drug

The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.

Other names: Triple Antibiotic Paste

Primary outcomes

  1. Change from Baseline in Postoperative Pain after Retreatment at 48 hours.

    Time frame: Baseline, 1, 6, 12, 24 and 48 hours.

    The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2017
Registry last updated
Mar 1, 2018

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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