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

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ClinicalTrials.gov Identifier: NCT03042377
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Keziban Olcay, Istanbul Medipol University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Root Canal Infection Endodontic Disease Other: Single-Visit Retreatment Drug: Multiple-Visit-"Calcium Hydroxide" Drug: Multiple-Visit-"Corticosteroid Paste" Drug: Multiple-Visit-"Antibiotic Paste" Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
Masking: Single (Participant)
Masking Description: The patients were unaware as to which study group they had been allocated.
Primary Purpose: Treatment
Official Title: The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : July 30, 2015
Actual Study Completion Date : August 30, 2015

Arm Intervention/treatment
Active Comparator: Single-Visit Retreatment
Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.
Other: Single-Visit Retreatment
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 Name: Single-Visit Root Canal Therapy

Active Comparator: Multiple-Visit-"Calcium Hydroxide"
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Drug: Multiple-Visit-"Calcium Hydroxide"
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 Name: Calcium Hydroxide

Active Comparator: Multiple-Visit-"Corticosteroid Paste"
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Drug: Multiple-Visit-"Corticosteroid Paste"
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 Name: Ledermix Paste

Active Comparator: Multiple-Visit-"Antibiotic Paste"
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Drug: Multiple-Visit-"Antibiotic Paste"
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 Name: Triple Antibiotic Paste




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042377


Locations
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Turkey
Istanbul Medipol University
Istanbul, Turkey, 34083
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Principal Investigator: Keziban Olcay, DDS. PhD. Medipol University
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Responsible Party: Keziban Olcay, Assistant Professor, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03042377    
Other Study ID Numbers: 156
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keziban Olcay, Istanbul Medipol University Hospital:
Endodontics
Retreatment
Postoperative Pain
Visual Analogue Pain Scale
Additional relevant MeSH terms:
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Dental Pulp Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Infective Agents
Antitubercular Agents