NCT06412263

Brief Summary

This study is a prospective clinical study, which evaluates pain following the completion of non-surgical root canal treatment and re-treatment cases. Additionally, the effect of the post-operative pain on the quality of life (QoL) is also evaluated. The main objectives are: To evaluate the (i) incidence of post-operative pain after RCT at 24 hours, 48 hours and 7 days, (ii) factors affecting the incidence of post-operative pain and (iii) patients' post- operative quality of life (PoQoL) at 24 hours, 48 hours and 7 days. 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. Patients who have consented to participate in the study will provide a written consent prior to the start of the study. Following this, the pre-operative pain assessment will be performed by their respective clinicians, based on the approved questionnaire. Following the completion of the root canal treatment, for both post-instrumentation and post-obturation, the patients will be called by the principle investigator for the post-operative pain assessment at 24 hours, 48 hours and 7 days. The post-operative quality of life (QoL) will also be assessed via the phone call, at the same three time points. These assessments will be made based on an approved questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

February 3, 2025

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 8, 2024

Last Update Submit

January 29, 2025

Conditions

Post-operative PainQuality of Life

Keywords

Post-operative painRoot canal treatmentRoot canal retreatmentQoLPoQoL

Outcome Measures

Primary Outcomes (3)

  • Post-operative pain (both post-instrumentation and post-obturation)

    This study assesses pain after root canal treatment at 24 hours, 48 hours and 7 days for both single-visit and multiple-visit treatment, based on the following pain instruments: i) Numeric Rating Scaling, scores 0-10 with score 0 as no pain, scores 1-3 as mild pain, scores 4-6 as moderate pain and scores 7-10 as severe pain and ii) Modified Verbal Rating scale with scores 0-3, whereby score 0 as no pain, score 1 as mild pain and no analgesics required, score 2 moderate pain which can be controlled by analgesics and score 3 as severe pain that cannot be controlled by analgesics.

    5 November 2021 until May 2023

  • Post-operative quality of life

    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 24 hours 48 hours and 7 days, answered as yes or no.

    5 November 2021 until May 2023

  • Pre-operative factors affecting the incidence of post-operative pain following root canal treatment

    Factors affecting post-operative pain at 24 hours, 48 hours, 7 days.

    5 November 2021 until May 2023

Secondary Outcomes (2)

  • Duration of post-operative pain

    5 November 2021 until May 2023

  • Severity of post-operative pain

    5 November 2021 until May 2023

Study Arms (4)

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

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

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

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

Interventions

Routine root canal treatment/ retreatmentPROCEDURE

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)Post-operative quality of life unaffected (Assessed at 24 hours, 48 hours, 7 days)With post-operative pain (Assessed at 24 hours, 48 hours, 7 days)Without post-operative pain (Assessed at 24 hours, 48 hours, 7 days)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Related Publications (4)

  • Mijiritsky E, Lerman Y, Mijiritsky O, Shely A, Meyerson J, Shacham M. Development and Validation of a Questionnaire Evaluating the Impact of Prosthetic Dental Treatments on Patients' Oral Health Quality of Life: A Prospective Pilot Study. Int J Environ Res Public Health. 2020 Jul 13;17(14):5037. doi: 10.3390/ijerph17145037.

    PMID: 32668778BACKGROUND

  • Pasqualini D, Corbella S, Alovisi M, Taschieri S, Del Fabbro M, Migliaretti G, Carpegna GC, Scotti N, Berutti E. Postoperative quality of life following single-visit root canal treatment performed by rotary or reciprocating instrumentation: a randomized clinical trial. Int Endod J. 2016 Nov;49(11):1030-1039. doi: 10.1111/iej.12563. Epub 2015 Nov 5.

    PMID: 26468626BACKGROUND

  • Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.

    PMID: 23402273RESULT

  • Fuad NA, Philpott RJ, Cresta M. Post-operative pain as a risk factor for reduced quality of life after root canal treatment: A prospective clinical study. Saudi Dent J. 2025 Jun 18;37(4-6):21. doi: 10.1007/s44445-025-00006-1.

    PMID: 40528109DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Retreatment

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Natrah A Fuad, BDS

    Edinburgh Dental Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 14, 2024

Study Start

November 5, 2021

Primary Completion

April 30, 2023

Study Completion

May 3, 2023

Last Updated

February 3, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)