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

Comparative Evaluation of the Effect of Three Different Root-canal Medicaments on Post-operative Pain in Re-treatment Cases: a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05052814
Enrollment
120
Registered
2021-09-22
Start date
2019-03-23
Completion date
2020-08-23
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth

Keywords

retreatment

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.

Detailed description

Introduction: The aim of this study was to compare the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases. Methods: One hundred twenty patients with asymptomatic teeth with single-root, single-canal without spontaneous pain or swelling were included in the present study. All patients were previously undergone endodontic treatment but still had periapical radiolucencies. Patients were randomly and equally divided into three groups in which stratified randomization was performed based on the gender and the age of the patients. Intracanal medicaments were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Calcium hydroxide (Ca(OH)2), chlorhexidine gel (CHX), calcium hydroxide, and chlorhexidine gel combinations were used as intracanal medicaments in the present study. Postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using a visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were evaluated during clinical examinations performed postoperatively after 2 and 7 days. p.

Interventions

OTHERroot canal medicament-calcium hydroxide

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.

OTHERroot canal medicament-chlorhexidine gel

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.

OTHERroot canal medicament-calcuim hyroxide &chlorhexidine ge

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.

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients between 20 - 65 years of ages 2. Patients who agree to participate this study 3. Not taking analgesic or antibiotics in the last week 4. Single root and single-canal incisor, canine, premolar teeth that have been treated only once before 5. Teeth with previous endodontic treatment but with insufficient root canal filling on radiographic examination 6. Teeth with periapical lesions and at least 2 years since the previous treatment, although root canal filling seems sufficient 7. Periapical radiolucency, teeth with increased or unchanged according to pre-treatment radiography (if available) 8. Teeth are asymptomatic 9. Patients who had good oral hygiene

Exclusion criteria

1. Pregnant patients and patients in lactation period 2. Having used corticosteroids in the last 6 months 3. Individuals with systemic diseases (endocarditis, immune system diseases,etc.) requiring antibiotic prophylaxis 4. Having received immunosuppressive therapy within the last week 5. Patients who had systemic or allergic sensitivty for the NSAIDs and local ananesthetics 6. The presence of advanced periodontal disease (probing depth \> 4 mm) 7. The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.) 8. Fracture or crack in the root 9. Teeth that cannot reach the working length due to calcification in the root canal and step formation 10. Teeth that cannot be restored due to excessive loss of material in the coronal structure 11. The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient. 12. 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours.6 th hoursBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th hours.12 th hourBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 24th hours.24 th hourBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 2nd days.2nd daysBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 3th days.3th daysBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 4th days.4th daysBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 5th days.5th daysBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th days.6th daysBased 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.
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 7th days.7th daysBased 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026