Postoperative Pain Endodontic Retreatment

Incidence Postoperative Pain After Single Visit Versus Two Visit Nonsurgical Endodontic Retreatment

To compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.

Study Overview

• Status: Unknown
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: Non-surgical endodontic retreatment in single visit

Detailed Description

Post treatment failure could be treated by two options including orthograde retreatment and apical surgery . In a previous study, orthograde retreatments presented a success rate of 81 % classified as healed and 93 % as no symptoms and fully functional. In a systematic review, it has also been concluded that endodontic surgery offers more favorable initial success but orthograde retreatment yields to a better long-term outcome . Although early results of single-visit treatments are contradictory ; Completing the treatment in a single appointment reduces the treatment time and cost, decreases micro leakage risk and avoids recontamination of root canals between appointments in multiple-visit treatments . Again, reviewing the literature concerning primary treatment showed that, no significant differences were observed in healing of periapical radiolucency between teeth treated in single-visit and those treated in two-visits. Even, after using calcium hydroxide for four weeks . The presence of a positive bacterial culture at the time of filling did not influence the outcome of treatment .

Thorough online search revealed that, few studies are found concerning post- operative pain after single visit retreatment . The present study is designed to compare the effects of single-visit and two-visit root canal treatments on postoperative pain in retreatment cases. The primary outcome measure of this study is proposed to be whether single-visit root canal retreatment influenced the occurrence of postoperative pain as compared to two-visit treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically asymptomatic.
• Previously treated teeth in need of retreatment due to leakage and/or improper filling.
• No periapical radiolucency.
• No percussion pains.
• Age 20 - 45.
• Premolar teeth.
• Male & female.

Exclusion Criteria:

• Complicating compromised patient.
• Tenderness to percussion and acute apical abscess.
• Presence of an associated sinus tract.
• Presence of swelling in adjacent soft tissue.
• Teeth with periodontal pathologies or mobility.
• Teeth representing root fracture.
• Pregnant women.
• If analgesics or antibiotics have been administrated by the patient during the past 24 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1 Non-surgical endodontic retreatment in single visit; Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments	Other: Non-surgical endodontic retreatment in single visit; Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.; Other Names: Non-surgical endodontic retreatment in Two-visit
Active Comparator: group 2 Non-surgical endodontic retreatment in Two-visit; Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth	Other: Non-surgical endodontic retreatment in single visit; Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.; Other Names: Non-surgical endodontic retreatment in Two-visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and intensity of postoperative	Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment	At one week after each visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of analgesic tablets	Number of analgesic tablets taken by the patient after endodontic retreatment	baseline

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital
• Other Study ID Numbers: pop rct

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No