Post-operative PainNCT06412263
Post-operative Pain and QoL After RCT
An observational study of Post-operative Pain and Quality of Life, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-operative Pain, Quality of Life
- What is being tested?
- Routine root canal treatment/ retreatment
- Type of treatment
- Surgery or procedure
- How many people
- 162 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2021to 3 May 2023
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Those who have completed non-surgical nerve treatment (root canal treatment) and re-do nerve treatment (root canal re-treatment) cases.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Periodontally involved teeth
- Cases with hypochlorite accident
- Short or extruded root canal obturation
- Cases whereby canal patency was not achieved
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Post-operative Pain and Quality of Life 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. 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.
Read the detailed description
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.
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. 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. 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. 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 a questionnaire. 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'.
- Conditions
- Post-operative Pain, Quality of Life
- Being tested
- Routine root canal treatment/ retreatment
- Keywords
- Post-operative pain, Root canal treatment, Root canal retreatment, QoL, PoQoL
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine root canal treatment/ retreatmentProcedure or surgery
It is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Routine root canal treatment/ retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 November 2021 until May 2023
Secondary outcomes (2)
Duration of post-operative pain
The duration of post-operative pain will be measured within the 7 days post-treatment
Measured: 5 November 2021 until May 2023
Severity of post-operative pain
The severity of post-operative pain will be measured based on the numeric rating scale (NRS) and modified verbal rating scale (MVRS) based on the pain severity, whereby severe pain on the NRS ranges from 7-10 and a score 3 on the MVRS. Additionally, the need for painkillers and whether the painkillers are affective in managing the pain felt will also be an indirect measure of pain severity.
Measured: 5 November 2021 until May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start5 Nov 2021
- Primary completion30 Apr 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Natrah A Fuad, BDS, Principal investigator, Edinburgh Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412263
- Sponsor's protocol ID
- 295316
- Other IDs
- Protocol number: AC21057, REC Number: 21/YH/0180, Project no.: 2021/0159
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32668778Pasqualini 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.
PubMed 26468626Arias 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.
PubMed 23402273Fuad 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.
PubMed 40528109
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Post-operative Pain and Quality of Life Following Root Canal Treatment: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06412263
- Acronym / sponsor ID
- 295316
- Conditions
- Post-operative Pain, Quality of Life
- Keywords
- Post-operative pain, Root canal treatment, Root canal retreatment, QoL, PoQoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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. 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. 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. 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 a questionnaire. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| With post-operative pain (Assessed at 24 hours, 48 hours, 7 days) | – | Procedure: Routine root canal treatment/ retreatmentRoot 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. |
| Without post-operative pain (Assessed at 24 hours, 48 hours, 7 days) | – | Procedure: Routine root canal treatment/ retreatmentRoot 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. |
| Post-operative quality of life affected (Assessed at 24 hours, 48 hours, 7 days) | – | Procedure: Routine root canal treatment/ retreatmentQuality 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. |
| Post-operative quality of life unaffected (Assessed at 24 hours, 48 hours, 7 days) | – | Procedure: Routine root canal treatment/ retreatmentQuality 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Those who have completed non-surgical nerve treatment (root canal treatment) and re-do nerve treatment (root canal re-treatment) cases.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine root canal treatment/ retreatmentIt is a routine clinical procedure involving root canal treatment/ retreatment and pain assessment after the treatment | Procedure or surgery | 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) |
Primary outcome
Post-operative pain (both post-instrumentation and post-obturation)
Time frame: 5 November 2021 until May 2023
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.
Post-operative quality of life
Time frame: 5 November 2021 until May 2023
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.
Pre-operative factors affecting the incidence of post-operative pain following root canal treatment
Time frame: 5 November 2021 until May 2023
Factors affecting post-operative pain at 24 hours, 48 hours, 7 days.
2 secondary outcomes
Duration of post-operative pain
Time frame: 5 November 2021 until May 2023
Severity of post-operative pain
Time frame: 5 November 2021 until May 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 32668778Mijiritsky 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.
- Background: PubMed 26468626Pasqualini 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.
- Results publication: PubMed 23402273Arias 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.
- Derived from this study: PubMed 40528109Fuad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natrah A Fuad, BDS principal investigator
Edinburgh Dental Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Pain and Quality of Life, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (both post-instrumentation and post-obturation) (time frame: 5 November 2021 until May 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412263, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.