PediatricNCT07181252
Comparison of Post-operative Pain in Relation to Working Length Assessment by Electronic Apex Locator and Digital Radiography in Permanent Teeth Among Pediatric Patients
An observational study of Pediatric and Radiography, run by Jouf University at 1 site in Saudi Arabia.
Trial summary
This randomized, double-blind clinical trial was conducted at the College of Dentistry, Jouf University, Kingdom of Saudi Arabia, between August 2024 and February 2025. A total of 130 pediatric patients were recruited from the outpatient department. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Radiography
- What is being tested?
- Working length of root
- How many people
- 130 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2024to 28 Feb 2025
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients
Who may be able to join
- Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian.
Who cannot join
- Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Jouf University
Sakakah, Al Jawf Region, 75432
About this study
This randomized, double-blind clinical trial was conducted at the College of Dentistry, Jouf University, Kingdom of Saudi Arabia, between August 2024 and February 2025. A total of 130 pediatric patients were recruited from the outpatient department.
Read the detailed description
Sample Size and Participants The sample size was calculated based on a previous study by Guzel et al. [16], which assessed post-operative pain in relation to different working length determination methods. To detect a 10% difference in mean pain scores with 95% confidence and 80% power, a minimum sample of 124 participants was required. Accounting for a 5-10% attrition rate, the final sample size was increased to 130 (65 in each group).
Inclusion Criteria Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian. Exclusion Criteria Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions. Randomization and Blinding
Participants were randomly allocated into two groups using the coin-flip method:
EAL group: Working length determination using EAL DR group: Working length determination using DR The participants and the investigator of post-operative pain were blinded to the group allocation. All clinical procedures were carried out by a single experienced endodontist who was not involved in pain assessment.
Clinical Procedure All root canal treatments were completed in a single visit under local anesthesia using 2% lignocaine with 1:80,000 epinephrine. Caries excavation and access cavity preparation were performed using sterilized high- and low-speed burs. Patency was confirmed using a #10 K-file.
EAL Group: Working length was measured using the Root ZX apex locator (J. Morita Corp., Kyoto, Japan), following the manufacturer's instructions. A #15 K-file was connected to the device and advanced until the display indicated "APEX," confirming the location beyond the apical foramen.
DR Group: Working length was determined using a #15 K-file inserted 1 mm short of the estimated radiographic apex. A digital periapical radiograph was taken, and the working length was adjusted accordingly. Repeated radiographs were obtained until the file tip was 1 mm short of the radiographic apex.
Canal instrumentation was performed using ProTaper Universal NiTi rotary instruments (Dentsply Maillefer, Switzerland) in a crown-down technique. After initial coronal flaring with an SX file, canals were shaped using S1 and S2 files, followed by F1-F3 files up to 1 mm short of the working length. Irrigation was performed with 2.5% sodium hypochlorite throughout the procedure. Final obturation was completed using the lateral compaction technique with gutta-percha cones and resin-based sealer, followed by restoration with composite resin.
Pain Assessment Pain was evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 denoted "worst possible pain." Participants were trained to use the scale pre-operatively and were provided with printed forms to record pain at specific post-operative intervals: 6 hours, 12 hours, 24 hours, 48 hours, and 7 days. Pre-operative pain scores were recorded before starting the procedure. This method has been widely used in pediatric endodontic research for subjective pain evaluation [17].
Statistical Analysis Data was analyzed using Statistical Package for Social Sciences version 22.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were computed for demographic variables. The Chi-square test was used to compare categorical variables such as incidence of post-operative pain between groups. Independent samples t-test was used to compare mean VAS scores between groups, while paired t-test was used to compare pre- and post-operative scores within each group. One-way ANOVA was employed to assess mean VAS scores across different post-operative time intervals. A p-value ≤0.05 was considered statistically significant.
- Conditions
- Pediatric, Radiography
- Being tested
- Working length of root
- Keywords
- Digital radiography, Electronic apex locator, Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working length of rootDiagnostic test
EAL Group: Working length was measured using the Root ZX apex locator (J. Morita Corp., Kyoto, Japan), following the manufacturer's instructions. A #15 K-file was connected to the device and advanced until the display indicated "APEX," confirming the location beyond the apical foramen.
DR Group: Working length was determined using a #15 K-file inserted 1 mm short of the estimated radiographic apex. A digital periapical radiograph was taken, and the working length was adjusted accordingly. Repeated radiographs were obtained until the file tip was 1 mm short of the radiographic apex.
| Study group | Role | What they receive |
|---|---|---|
| EAL group | Working length determination using EAL Receives: Diagnostic Test: Working length of root | |
| DR group | Working length determination using DR Receives: Diagnostic Test: Working length of root |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-operative pain assessment
Pain was evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 denoted "worst possible pain." Participants were trained to use the scale pre-operatively and were provided with printed forms to record pain at specific post-operative intervals: 6 hours, 12 hours, 24 hours, 48 hours, and 7 days. Pre-operative pain scores were recorded before starting the procedure. This method has been widely used in pediatric endodontic research for subjective pain evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Aug 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakhi Issrani, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181252
- Sponsor's protocol ID
- LCBE 24-03/41
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain in Relation to Working Length Assessment by Electronic Apex Locator and Digital Radiography in Permanent Teeth Among Pediatric Patients
- ClinicalTrials.gov ID
- NCT07181252
- Acronym / sponsor ID
- LCBE 24-03/41
- Conditions
- Pediatric, Radiography
- Keywords
- Digital radiography, Electronic apex locator, Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 18 Sep 2025 (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 randomized, double-blind clinical trial was conducted at the College of Dentistry, Jouf University, Kingdom of Saudi Arabia, between August 2024 and February 2025. A total of 130 pediatric patients were recruited from the outpatient department.
Detailed description
Sample Size and Participants The sample size was calculated based on a previous study by Guzel et al. [16], which assessed post-operative pain in relation to different working length determination methods. To detect a 10% difference in mean pain scores with 95% confidence and 80% power, a minimum sample of 124 participants was required. Accounting for a 5-10% attrition rate, the final sample size was increased to 130 (65 in each group).
Inclusion Criteria Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian. Exclusion Criteria Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions. Randomization and Blinding
Participants were randomly allocated into two groups using the coin-flip method:
EAL group: Working length determination using EAL DR group: Working length determination using DR The participants and the investigator of post-operative pain were blinded to the group allocation. All clinical procedures were carried out by a single experienced endodontist who was not involved in pain assessment.
Clinical Procedure All root canal treatments were completed in a single visit under local anesthesia using 2% lignocaine with 1:80,000 epinephrine. Caries excavation and access cavity preparation were performed using sterilized high- and low-speed burs. Patency was confirmed using a #10 K-file.
EAL Group: Working length was measured using the Root ZX apex locator (J. Morita Corp., Kyoto, Japan), following the manufacturer's instructions. A #15 K-file was connected to the device and advanced until the display indicated "APEX," confirming the location beyond the apical foramen.
DR Group: Working length was determined using a #15 K-file inserted 1 mm short of the estimated radiographic apex. A digital periapical radiograph was taken, and the working length was adjusted accordingly. Repeated radiographs were obtained until the file tip was 1 mm short of the radiographic apex.
Canal instrumentation was performed using ProTaper Universal NiTi rotary instruments (Dentsply Maillefer, Switzerland) in a crown-down technique. After initial coronal flaring with an SX file, canals were shaped using S1 and S2 files, followed by F1-F3 files up to 1 mm short of the working length. Irrigation was performed with 2.5% sodium hypochlorite throughout the procedure. Final obturation was completed using the lateral compaction technique with gutta-percha cones and resin-based sealer, followed by restoration with composite resin.
Pain Assessment Pain was evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 denoted "worst possible pain." Participants were trained to use the scale pre-operatively and were provided with printed forms to record pain at specific post-operative intervals: 6 hours, 12 hours, 24 hours, 48 hours, and 7 days. Pre-operative pain scores were recorded before starting the procedure. This method has been widely used in pediatric endodontic research for subjective pain evaluation [17].
Statistical Analysis Data was analyzed using Statistical Package for Social Sciences version 22.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were computed for demographic variables. The Chi-square test was used to compare categorical variables such as incidence of post-operative pain between groups. Independent samples t-test was used to compare mean VAS scores between groups, while paired t-test was used to compare pre- and post-operative scores within each group. One-way ANOVA was employed to assess mean VAS scores across different post-operative time intervals. A p-value ≤0.05 was considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAL group | – | Diagnostic Test: Working length of rootWorking length determination using EAL |
| DR group | – | Diagnostic Test: Working length of rootWorking length determination using DR |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients
Key inclusion criteria (1 listed)
- Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian.
Key exclusion criteria (1 listed)
- Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions.
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 |
|---|---|---|
| Working length of rootEAL Group: Working length was measured using the Root ZX apex locator (J. Morita Corp., Kyoto, Japan), following the manufacturer's instructions. A #15 K-file was connected to the device and advanced until the display indicated "APEX," confirming the location beyond the apical foramen. DR Group: Working length was determined using a #15 K-file inserted 1 mm short of the estimated radiographic apex. A digital periapical radiograph was taken, and the working length was adjusted accordingly. Repeated radiographs were obtained until the file tip was 1 mm short of the radiographic apex. | Diagnostic test | DR group, EAL group |
Primary outcome
Pre- and post-operative pain assessment
Time frame: 1 year
Pain was evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 denoted "worst possible pain." Participants were trained to use the scale pre-operatively and were provided with printed forms to record pain at specific post-operative intervals: 6 hours, 12 hours, 24 hours, 48 hours, and 7 days. Pre-operative pain scores were recorded before starting the procedure. This method has been widely used in pediatric endodontic research for subjective pain evaluation
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 18 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric and Radiography, run by Jouf University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 18 Sep 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 Saudi Arabia. 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?
Pre- and post-operative pain assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.