Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth

NCT04310254 | Completed

• 1 other identifier: 929
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after root canal treatment using different final irrigation protocols. Patients whom need root canal treatment for first time were included. The presence of postoperative pain was assessed after root canal treatment cases at 12, 24, 48, 72 hrs and 1 week.

Conditions

Postoperative Pain; Endodontically Treated Teeth

Keywords

Endodontics; Postoperative Pain; Visual Analogue Pain Scale

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week.

  The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root canal treatment 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 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS 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 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.

  Baseline, 12, 24, 48, 72 hours and 1 week.

Study Arms (3)

EDTA and CHX solution

ACTIVE COMPARATOR

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA and CHX solution.

Procedure: EDTA and CHX Solution

EDTA solution

ACTIVE COMPARATOR

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA solution.

Procedure: EDTA Solution

CHX solution

ACTIVE COMPARATOR

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for CHX solution.

Procedure: CHX Solution

Interventions

EDTA and CHX Solution PROCEDURE

The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with Qmix 2in1 solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.

EDTA and CHX solution

EDTA Solution PROCEDURE

The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with EDTA solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.

EDTA solution

CHX Solution PROCEDURE

The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with CHX solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.

CHX solution

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 healthy volunteers and who have devital premolar and molar teeth with PAI 3-5score requiring root canal treatment for first time.
• 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 days,
• have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
• have root canals that could not be well-treated with orthograde root canal treatment.

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; Tooth, Nonvital

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Keziban Olcay, DDS, Phd

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant and Outcomes Assessor) The patients were unaware as to which study group they had been allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment The patients were assigned to 3 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: September 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-03

Locations

TU (1)