Periapical PeriodontitisIMAP-PainNCT07239752
Influence of Maintaining Apical Patency on Post-Endodontic Pain in Molars
A study testing Patency Group and Standard Root Canal Instrumentation in people with Periapical Periodontitis and Dental Pulp Necrosis, run by College of Physicians and Surgeons Pakistan.
Trial summary
This randomized controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periapical Periodontitis, Dental Pulp Necrosis
- What is being tested?
- Patency Group and Standard Root Canal Instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically healthy, classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- Presence of a single permanent molar tooth diagnosed with necrotic pulp and symptomatic apical periodontitis, and indicated for primary root canal treatment.
- Patients who provide informed written consent to participate in the study. -
Who cannot join
- Teeth with prior endodontic treatment or complex anatomy (e.g., calcified canals, severe curvature).
- Patients with significant systemic illness (e.g., uncontrolled diabetes, immunocompromised status) or pregnancy.
- History of analgesic intake within 72 hours prior to the root canal procedure.
- Non-restorable teeth, teeth with severe periodontal disease (pocket depth >5mm), or teeth with root fractures.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Influence of Maintaining Apical Patency in Post-Endodontic Pain in Molars With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial
This randomized controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. The study will include 48 adult patients needing root canal treatment on a back molar tooth with a dead nerve and infection at the root tip. Participants will be randomly assigned to one of two groups: one where the apical patency technique is used, and one where it is not. All other treatment steps will be identical. Patients will record their pain levels on a standard scale (0-100 mm Visual Analog Scale) at 6, 12, 24, 48, and 72 hours after the procedure. The goal is to determine if this specific technique influences the intensity and duration of post-treatment pain
Read the detailed description
BACKGROUND: Post-operative pain remains a significant challenge in endodontics, impacting patient satisfaction. The clinical practice of maintaining apical patency-passively keeping the apical foramen patent with a small file-is debated, with conflicting evidence on its impact on post-endodontic pain. This study aims to provide clear evidence from a robust randomized controlled trial.
OBJECTIVE: To determine the influence of maintaining apical patency on the intensity and duration of post-endodontic pain in molars with necrotic pulp and apical periodontitis.
METHODS:
Study Design: Single-center, randomized, controlled, parallel-group trial.
Setting: Department of Operative Dentistry, Saidu College of Dentistry, Swat.
Participants: 48 adult patients (aged 18-65, ASA I/II) with a single permanent molar diagnosed with necrotic pulp and symptomatic apical periodontitis. Patients with prior endodontic treatment, complex anatomy, systemic illness, pregnancy, recent analgesic use, or non-restorable teeth will be excluded.
Intervention:
Patency Group (Experimental): Following determination of working length with an electronic apex locator (verified radiographically), a pre-curved size #10 K-file will be passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size.
Non-Patency Group (Active Comparator): Instrumentation will be carefully confined to the root canal space and will not proceed beyond the apical foramen.
Procedure: All participants will receive single-visit root canal treatment under local anesthesia and rubber dam isolation. Cleaning and shaping will be performed using a rotary instrument system. Irrigation will be performed with sodium hypochlorite and EDTA. Obturation will be completed with gutta-percha and sealer via a standardized technique, followed by a composite restoration.
Outcome Measure: The primary outcome is post-operative pain intensity, measured using a 100-mm Visual Analog Scale (VAS). Patients will self-record their pain levels at 6, 12, 24, 48, and 72 hours post-operatively.
Data Analysis: Data will be analyzed using SPSS Statistics v25. Descriptive statistics will summarize the data. The distribution of pain severity categories will be compared using the Chi-square test. Mean VAS scores between groups will be compared using independent samples t-tests (assuming normal distribution). A p-value of < 0.05 will be considered statistically significant.
- Conditions
- Periapical Periodontitis, Dental Pulp Necrosis
- Being tested
- Patency Group, Standard Root Canal Instrumentation
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patency GroupProcedure or surgery
The procedural technique of passively advancing a small endodontic file (size #10 K-file) 1 mm beyond the apical foramen before and after each larger instrument during root canal cleaning and shaping. This is done to prevent blockage of the apical portion of the canal.
Standard Root Canal InstrumentationProcedure or surgery
Root canal instrumentation that is strictly confined to the canal space, terminating at the apical constriction (working length) and avoiding any instrumentation beyond the apical foramen.
| Study group | Role | What they receive |
|---|---|---|
| Patency Group | Experimental | : A #10 K-file is passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size to maintain patency. Receives: Procedure: Patency Group; Procedure: Standard Root Canal Instrumentation |
| Non-Patency Group | Active comparator | Participants in this group will receive standard root canal treatment where instruments are carefully confined to the root canal space and do not proceed beyond the apical foramen. All other aspects of the treatment are identical to the Experimental arm. Receives: Procedure: Patency Group; Procedure: Standard Root Canal Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Intensity
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 6 hours after the completion of the root canal procedure
Post-operative Pain Intensity at 6 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 6 hours after the completion of the root canal procedure.
Post-operative Pain Intensity at 12 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 12 hours
Post-operative Pain Intensity at 48 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 48 hours
Post-operative Pain Intensity
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 12 hours after the completion of the root canal procedure
Post-operative Pain Intensity
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Measured: 24 hours
Secondary outcomes (2)
ncidence of Post-operative Pain Severity
The proportion of participants in each group reporting different levels of pain severity, categorized based on their VAS scores. The categories are: No Pain (VAS = 0 mm), Moderate Pain (VAS = 1-54 mm), and Severe Pain (VAS = 55-100 mm).
Measured: Assessed at 6, 12, 24, 48, and 72 hours after the procedure
ncidence of Post-operative Pain Severity
The proportion of participants in each group reporting different levels of pain severity, categorized based on their VAS scores. The categories are: No Pain (VAS = 0 mm), Moderate Pain (VAS = 1-54 mm), and Severe Pain (VAS = 55-100 mm).
Measured: Assessed at 6, 12, 24, 48, and 72 hours after the procedure. The data from all time points will be aggregated to compare the overall distribution of pain severity between groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Feb 2026 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiz ur rahman, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239752
- Sponsor's protocol ID
- SCD-Endo-Patency-001
- Acronym
- IMAP-Pain
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Maintaining Apical Patency in Post-Endodontic Pain in Molars With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07239752
- Acronym / sponsor ID
- IMAP-Pain / SCD-Endo-Patency-001
- Conditions
- Periapical Periodontitis, Dental Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 20 Nov 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 controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. The study will include 48 adult patients needing root canal treatment on a back molar tooth with a dead nerve and infection at the root tip. Participants will be randomly assigned to one of two groups: one where the apical patency technique is used, and one where it is not. All other treatment steps will be identical. Patients will record their pain levels on a standard scale (0-100 mm Visual Analog Scale) at 6, 12, 24, 48, and 72 hours after the procedure. The goal is to determine if this specific technique influences the intensity and duration of post-treatment pain
Detailed description
BACKGROUND: Post-operative pain remains a significant challenge in endodontics, impacting patient satisfaction. The clinical practice of maintaining apical patency-passively keeping the apical foramen patent with a small file-is debated, with conflicting evidence on its impact on post-endodontic pain. This study aims to provide clear evidence from a robust randomized controlled trial.
OBJECTIVE: To determine the influence of maintaining apical patency on the intensity and duration of post-endodontic pain in molars with necrotic pulp and apical periodontitis.
METHODS:
Study Design: Single-center, randomized, controlled, parallel-group trial.
Setting: Department of Operative Dentistry, Saidu College of Dentistry, Swat.
Participants: 48 adult patients (aged 18-65, ASA I/II) with a single permanent molar diagnosed with necrotic pulp and symptomatic apical periodontitis. Patients with prior endodontic treatment, complex anatomy, systemic illness, pregnancy, recent analgesic use, or non-restorable teeth will be excluded.
Intervention:
Patency Group (Experimental): Following determination of working length with an electronic apex locator (verified radiographically), a pre-curved size #10 K-file will be passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size.
Non-Patency Group (Active Comparator): Instrumentation will be carefully confined to the root canal space and will not proceed beyond the apical foramen.
Procedure: All participants will receive single-visit root canal treatment under local anesthesia and rubber dam isolation. Cleaning and shaping will be performed using a rotary instrument system. Irrigation will be performed with sodium hypochlorite and EDTA. Obturation will be completed with gutta-percha and sealer via a standardized technique, followed by a composite restoration.
Outcome Measure: The primary outcome is post-operative pain intensity, measured using a 100-mm Visual Analog Scale (VAS). Patients will self-record their pain levels at 6, 12, 24, 48, and 72 hours post-operatively.
Data Analysis: Data will be analyzed using SPSS Statistics v25. Descriptive statistics will summarize the data. The distribution of pain severity categories will be compared using the Chi-square test. Mean VAS scores between groups will be compared using independent samples t-tests (assuming normal distribution). A p-value of < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patency Group | Experimental | Procedure: Patency Group, Procedure: Standard Root Canal Instrumentation: A #10 K-file is passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size to maintain patency. |
| Non-Patency Group | Active comparator | Procedure: Patency Group, Procedure: Standard Root Canal InstrumentationParticipants in this group will receive standard root canal treatment where instruments are carefully confined to the root canal space and do not proceed beyond the apical foramen. All other aspects of the treatment are identical to the Experimental arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically healthy, classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- Presence of a single permanent molar tooth diagnosed with necrotic pulp and symptomatic apical periodontitis, and indicated for primary root canal treatment.
- Patients who provide informed written consent to participate in the study. -
Key exclusion criteria (5 listed)
- Teeth with prior endodontic treatment or complex anatomy (e.g., calcified canals, severe curvature).
- Patients with significant systemic illness (e.g., uncontrolled diabetes, immunocompromised status) or pregnancy.
- History of analgesic intake within 72 hours prior to the root canal procedure.
- Non-restorable teeth, teeth with severe periodontal disease (pocket depth >5mm), or teeth with root fractures.
- -
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 |
|---|---|---|
| Patency GroupThe procedural technique of passively advancing a small endodontic file (size #10 K-file) 1 mm beyond the apical foramen before and after each larger instrument during root canal cleaning and shaping. This is done to prevent blockage of the apical portion of the canal. | Procedure or surgery | Non-Patency Group, Patency Group |
| Standard Root Canal InstrumentationRoot canal instrumentation that is strictly confined to the canal space, terminating at the apical constriction (working length) and avoiding any instrumentation beyond the apical foramen. | Procedure or surgery | Non-Patency Group, Patency Group |
Primary outcome
Post-operative Pain Intensity
Time frame: 6 hours after the completion of the root canal procedure
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 6 hours
Time frame: 6 hours after the completion of the root canal procedure.
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 12 hours
Time frame: 12 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 48 hours
Time frame: 48 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity
Time frame: 12 hours after the completion of the root canal procedure
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity
Time frame: 24 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
2 secondary outcomes
ncidence of Post-operative Pain Severity
Time frame: Assessed at 6, 12, 24, 48, and 72 hours after the procedure
ncidence of Post-operative Pain Severity
Time frame: Assessed at 6, 12, 24, 48, and 72 hours after the procedure. The data from all time points will be aggregated to compare the overall distribution of pain severity between groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Patency Group and Standard Root Canal Instrumentation in people with Periapical Periodontitis and Dental Pulp Necrosis, run by College of Physicians and Surgeons Pakistan.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faiz Rahman, BDS (+923451505838, faizr3702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Intensity (time frame: 6 hours after the completion of the root canal procedure). The study lists 6 primary outcomes in all. 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 20 Nov 2025.