The Effect of Root-canal Medicaments on Post-operative Pain in Re-treatment Cases

NCT05052814 | Completed

• 1 other identifier: 2019/079
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compares the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases.

Conditions

Endodontically Treated Teeth

Keywords

retreatment

Outcome Measures

Primary Outcomes (9)

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  6 th hours

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th hours.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  12 th hour

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 24th hours.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  24 th hour

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 2nd days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  2nd days

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 3th days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  3th days

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 4th days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  4th days

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 5th days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  5th days

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  6th days

• Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 7th days.

  Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  7th days

Study Arms (3)

Calcium hydroxide ( Ca(OH)2 )

EXPERIMENTAL

Root canal medicament which was placed into root canals with a lentulo spiral.

Other: root canal medicament-calcium hydroxide

Chlorhexidine gel (CHX gel)

EXPERIMENTAL

Root canal medicament which was placed into root canals with a lentulo spiral.

Other: root canal medicament-chlorhexidine gel

Calcium hydroxide+ CHX gel

EXPERIMENTAL

Root canal medicament which was placed into root canals with a lentulo spiral.

Other: root canal medicament-calcuim hyroxide &chlorhexidine ge

Interventions

root canal medicament-calcium hydroxide OTHER

Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

Calcium hydroxide ( Ca(OH)2 )

root canal medicament-chlorhexidine gel OTHER

Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

Chlorhexidine gel (CHX gel)

root canal medicament-calcuim hyroxide &chlorhexidine ge OTHER

Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

Calcium hydroxide+ CHX gel

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 20 - 65 years of ages
• Patients who agree to participate this study
• Not taking analgesic or antibiotics in the last week
• Single root and single-canal incisor, canine, premolar teeth that have been treated only once before
• Teeth with previous endodontic treatment but with insufficient root canal filling on radiographic examination
• Teeth with periapical lesions and at least 2 years since the previous treatment, although root canal filling seems sufficient
• Periapical radiolucency, teeth with increased or unchanged according to pre-treatment radiography (if available)
• Teeth are asymptomatic
• Patients who had good oral hygiene

You may not qualify if:

• Pregnant patients and patients in lactation period
• Having used corticosteroids in the last 6 months
• Individuals with systemic diseases (endocarditis, immune system diseases,etc.) requiring antibiotic prophylaxis
• Having received immunosuppressive therapy within the last week
• Patients who had systemic or allergic sensitivty for the NSAIDs and local ananesthetics
• The presence of advanced periodontal disease (probing depth \> 4 mm)
• The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.)
• Fracture or crack in the root
• Teeth that cannot reach the working length due to calcification in the root canal and step formation
• Teeth that cannot be restored due to excessive loss of material in the coronal structure
• The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient.
• Teeth that develop any complications ( breakage of endodontic file, perforation, inability to determine the working length with the apex finder) during the removal of the canal filling material.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Hicran Dönmez Özkan

Merkez, Aydın, Turkey (Türkiye)

Location

Related Publications (2)

• Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.

  PMID: 30054099 BACKGROUND

• Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

  PMID: 20647083 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 22, 2021
• Study Start: March 23, 2019
• Primary Completion: June 23, 2020
• Study Completion: August 23, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

TU (1)