Pain Following Root Canal Treatment (PfRCT)

Factors Affecting the Incidence of Pain Following Root Canal Treatment: A Prospective Clinical Study

This study is a prospective clinical study, which evaluates pain following the completion of non-surgical root canal treatment and re-treatment cases. The study is planned to take place from October 2021 until April 2022. Patient cohort would be patients referred to the Edinburgh Dental Institute for root canal treatment. Root canal treatment and re-treatment cases will be performed by Postgraduate Trainees (Years 1,2 and 3) in Endodontology and Prosthodontics, core trainees, specialist registrars in the Restorative Departments and staff members of the Restorative Department, Edinburgh Dental Institute. (Please refer to Appendix 1)

Patients who are deemed suitable for this study, screened by clinicians on duty during Restorative New Patient Clinics, will be invited to participate in this study. They will be given the Patient Information Sheet (PIS) at the beginning of the session and will be given time to decide on whether to participate in the study or not. If a suitable patient happens to not have the PIS and consent form during the 1st treatment visit, the patient will be provided with the PIS and consent form during the 1st treatment visit and will be given up to 24H to decide on participating in the study or not. The pre-operative assessment, which will include pain assessment will be conducted as per normal routine prior to the commencement of RCT. At 24H (+/- 2H) the Principal Investigator will call the patient to follow-up. If the patient has agreed to participate in the study, the 24H post-operative pain and quality of life assessment will be conducted at the same time. Once patients have agreed to participate, they will be required to provide written consent which will be attached together with the PIS. On the first treatment day, patients will be required to answer a pre-operative Pain Assessment Questionnaire, which will be answered in the presence of the clinician treating the patient, before the commencement of RCT. The Pain Questionnaire is the combination of Numeric Rating Scale (NRS) and Modified Verbal Rating Scale (MVRS) adapted from previous published studies, with the addition of question on the presence of pre-operative pain duration. The pre-operative questionnaire will incorporate questions on pain intensity, the need, name and dosage of painkillers used by the patient on that day, and the last dose taken (in hours) as well as the duration of pain felt, as the longer the duration of pre-operative pain felt has been associated with higher incidence of post-operative pain (Polycarpou et al., 2005). Also, pre-operative pain felt within the last 24 hours prior to root canal treatment has been associated with higher probability of post-operative pain (Arias et al., 2013).

Following the completion of treatment, patients will be provided with post-operative Pain Assessment Questionnaire, for the evaluation of post-operative pain. A copy of the pain questionnaire will be given to the patients which will be used as a guide when the pain history is obtained. This will be carried out verbally via phone by the main investigator of the study (NAF). Patients will not be required to return the forms to the institute.

In addition to pain evaluation, this Pain Questionnaire also incorporates the intake of painkillers taken. In the event that painkillers are taken by patients for pain control, patients are required to record the pain intensity before the consumption of painkillers, apart from recording the dosage and frequency of painkillers taken. Patients will be advised on the standard painkiller regimen as a post-operative instruction after the completion of RCT. Painkiller consumption is also an indirect measure of post-operative pain intensity, hence, that is why this has been added to the Pain Assessment Questionnaire. Apart from the pain assessment, post-operative quality of life post-treatment will also be assessed, based on the questionnaire adapted from Pasqualini et al., 2016 and Mijiritsky et al., 2020.

Patients will be given the liberty to pull out from the study at any time, throughout the duration of the study. Similarly, the investigator will also be able to remove patients from the study, throughout the duration of the study, in the event that the teeth being root-treated were faced with complications that may alter the accuracy of the study. Withdrawal or removal will be recorded in the 'Withdrawal/ Removal Form'.

Study Overview

• Status: Completed
• Conditions: Assessment of Pain After Root Canal Treatment
• Intervention / Treatment: Procedure: Routine root canal treatment/ retreatment

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • NHS Lothian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Those who have completed non-surgical nerve treatment (root canal treatment) and re-do nerve treatment (root canal re-treatment) cases.

Description

Inclusion Criteria:

• All teeth requiring primary root canal treatment (only 1 tooth per patient)
• All teeth requiring root canal re-treatment (only 1 tooth per patient)
• Age 18-100 years old (completely formed root apex)
• Permanent teeth
• Periodontal pocket depth < 4mm and with mobility within normal limits
• The ability to give informed consent

Exclusion Criteria:

• Surgical root canal treatment
• Patients on long term analgesics and steroids
• Primary teeth
• Teeth with procedural errors either being referred for the management or created during the procedure
• Traumatized teeth
• Teeth with open apices
• Periodontally involved teeth
• Cases with hypochlorite accident
• Short or extruded root canal obturation
• Cases whereby canal patency was not achieved

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With post-operative pain (Assessed at 24 hours, 48 hours, 7 days); Root canal treatment or retreatment performed either in single-visit or multiple-visit. Post-operative pain will then be assessed after instrumentation and obturation (completion) for multiple-visit and after obturation only for the single-visit treatment.	Procedure: Routine root canal treatment/ retreatment; It is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment
Without post-operative pain (Assessed at 24 hours, 48 hours, 7 days); Root canal treatment or retreatment performed either in single-visit or multiple-visit. Post-operative pain will then be assessed after instrumentation and obturation (completion) for multiple-visit and after obturation only for the single-visit treatment.	Procedure: Routine root canal treatment/ retreatment; It is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment
Post-operative quality of life affected (Assessed at 24 hours, 48 hours, 7 days); Quality of life after root canal treatment both after instrumentation and after treatment completed will be assessed at 24H, 48H, 7 days. Factors that will be looked at are the chewing ability, speaking ability, sleeping whether painkillers are required to sleep, ability to carry out daily functions, difficulty in social relations and the overall quality of life.	Procedure: Routine root canal treatment/ retreatment; It is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment
Post-operative quality of life unaffected (Assessed at 24 hours, 48 hours, 7 days); Quality of life after root canal treatment both after instrumentation and after treatment completed will be assessed at 24H, 48H, 7 days. Factors that will be looked at are the chewing ability, speaking ability, sleeping whether painkillers are required to sleep, ability to carry out daily functions, difficulty in social relations and the overall quality of life.	Procedure: Routine root canal treatment/ retreatment; It is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors affecting the incidence of pain following root canal treatment: A prospective clinical study	This study assesses pain after root canal treatment at 24H, 48H and 7 days for both single-visit and multiple-visit treatment.	5 November 2021 until April 2023 (tentatively)
Factors affecting the incidence of pain following root canal treatment: A prospective clinical study	It also looks at how the pain felt affects the patients' quality of life (QoL), which looked specifically at: i) difficulties in chewing, ii) difficulties in speaking, iii) difficulties in sleeping, iv) difficulties in performing daily functions, v) difficulties in performing social relations, vi) overall effects on the QoL at 24H, 48H and 7 days	5 November 2021 until April 2023 (tentatively)
Factors affecting the incidence of pain following root canal treatment: A prospective clinical study	Factors affecting post-operative pain at 24H, 48H, 7 days	5 November 2021 until April 2023 (tentatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors affecting the incidence of pain following root canal treatment: A prospective clinical study	Duration of post-operative pain	5 November 2021 until April 2023 (tentatively)
Factors affecting the incidence of pain following root canal treatment: A prospective clinical study	Severity of post-operative pain	5 November 2021 until April 2023 (tentatively)

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 295316; Protocol number: AC21057 (Other Identifier: NHS Health Research Authority); REC Number: 21/YH/0180 (Other Identifier: NHS Lothian); Project no.: 2021/0159 (Other Identifier: Lothian R&D)

Drug and device information, study documents

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