Pain Following Root Canal Treatment - Trial NCT06412263

Timeline & Enrollment

Primary Outcome

Factors affecting the incidence of pain following root canal treatment: A prospective clinical study,Factors affecting the incidence of pain following root canal treatment: A prospective clinical study,Factors affecting the incidence of pain following root canal treatment: A prospective clinical study

Summary

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'.

ICD-10 Classifications