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

NCT ID: NCT05052814

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-23
• Study Completion Date: 2020-08-23

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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Conditions

Endodontically Treated Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calcium hydroxide ( Ca(OH)2 )

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

Group Type: EXPERIMENTAL

root canal medicament-calcium hydroxide

Intervention Type: 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 which was placed into root canals with a lentulo spiral.

Group Type: EXPERIMENTAL

root canal medicament-chlorhexidine gel

Intervention Type: 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

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

Group Type: EXPERIMENTAL

root canal medicament-calcuim hyroxide &chlorhexidine ge

Intervention Type: 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.

Interventions

root 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.

Intervention Type: OTHER

root 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.

Intervention Type: OTHER

root 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Hicran Dönmez Özkan

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hicran Dönmez Özkan

Merkez, Aydın, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30054099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20647083 (View on PubMed)

Other Identifiers

2019/079

Identifier Type: -

Identifier Source: org_study_id