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

NCT03042377 | Completed Phase 4

• 1 other identifier: 156
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Root Canal Infection; Endodontic Disease

Keywords

Endodontics; Retreatment; Postoperative Pain; Visual Analogue Pain Scale

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Postoperative Pain after Retreatment at 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.

  Baseline, 1, 6, 12, 24 and 48 hours.

Study Arms (4)

Single-Visit Retreatment

ACTIVE COMPARATOR

Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.

Other: Single-Visit Retreatment

Multiple-Visit-"Calcium Hydroxide"

ACTIVE COMPARATOR

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Drug: Multiple-Visit-"Calcium Hydroxide"

Multiple-Visit-"Corticosteroid Paste"

ACTIVE COMPARATOR

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Drug: Multiple-Visit-"Corticosteroid Paste"

Multiple-Visit-"Antibiotic Paste"

ACTIVE COMPARATOR

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Drug: Multiple-Visit-"Antibiotic Paste"

Interventions

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.

Also known as: Single-Visit Root Canal Therapy

Single-Visit Retreatment

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.

Also known as: Calcium Hydroxide

Multiple-Visit-"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.

Also known as: Ledermix Paste

Multiple-Visit-"Corticosteroid 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.

Also known as: Triple Antibiotic Paste

Multiple-Visit-"Antibiotic Paste"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Dental Pulp Diseases

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Keziban Olcay, DDS. PhD.

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients were unaware as to which study group they had been allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 3, 2017
• Study Start: March 1, 2015
• Primary Completion: July 30, 2015
• Study Completion: August 30, 2015
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)