Clinical trial NCT05052814: The Effect of Root-canal Medicaments on Post-operative Pain in Re-treatment Cases
Official title: Comparative Evaluation of the Effect of Three Different Root-canal Medicaments on Post-operative Pain in Re-treatment Cases: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: retreatment
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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Eligibility criteria: 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.

Primary outcomes:
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours.
timeFrame: 6 th hours
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th hours.
timeFrame: 12 th hour
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 24th hours.
timeFrame: 24 th hour
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 2nd days.
timeFrame: 2nd days
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 3th days.
timeFrame: 3th days
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 4th days.
timeFrame: 4th days
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 5th days.
timeFrame: 5th days
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th days.
timeFrame: 6th days
measure: Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 7th days.
timeFrame: 7th days
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Hicran Dönmez Özkan
state: Aydın
Study officials:
References:
citation: 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.
citation: 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.