Asymptomatic Irreversible PulpitisNCT07648862
Comparing Post Operative Pain With and Without Apical Patency Technique in Asymptomatic Irreversible Pulpitis Teeth
A study testing Apical Patency Technique and Non-Patency Technique in people with Asymptomatic Irreversible Pulpitis, run by Bolan Medical Complex Hospital Quetta Pakistan at 1 site in Pakistan.
Trial summary
Primary Outcome - Measure Presence of postoperative pain Primary Outcome - Time Frame 24 hours post-treatment Primary Outcome - Description Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0) Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Asymptomatic Irreversible Pulpitis
- What is being tested?
- Apical Patency Technique and Non-Patency Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2026to 15 Nov 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Age 20-50 years; maxillary or mandibular first/second premolar; diagnosed with asymptomatic irreversible pulpitis (no history of spontaneous pain; caries extending ≥2/3 into dentine; no tenderness to percussion/palpation; exaggerated, prolonged response to pulp vitality testing - cold, hot, or EPT)
Exclusion Criteria Uncontrolled diabetes mellitus; uncontrolled hypertension; bleeding disorder; use of anticoagulant therapy; active peptic ulcer; ischemic heart disease; compromised hepatic or renal function; immature apex; internal or external root resorption; blocked or sclerosed canal; periapical radiolucency; acute apical periodontitis; grade 3 mobility; root fracture; teeth in which patency cannot be maintained; symptomatic irreversible pulpitis; non-restorable teeth; retreatment cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Operative Dentistry, Bolan Medical Complex Hospital Unit 2
Quetta, Balochistan, 87300
About this study
Primary Outcome - Measure Presence of postoperative pain Primary Outcome - Time Frame 24 hours post-treatment Primary Outcome - Description Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)
Read the detailed description
Apical patency is a root canal preparation technique in which a small flexible K-file is passively passed just beyond the apical foramen to maintain canal permeability and prevent apical debris accumulation. Although this method improves irrigation flow to the apical third and reduces the risk of canal blockage, ledge formation, and transportation, its association with postoperative pain remains debatable. This randomized clinical trial aims to compare the frequency of postoperative pain between two treatment protocols in patients with asymptomatic irreversible pulpitis involving maxillary or mandibular premolars. Participants will be randomly allocated into two equal groups. In the Apical Patency Group (APG), a pre-curved #10 K-file will be gently passed 0.5 mm beyond the radiographic working length after each rotary instrument, without filing motion. In the Non-Patency Group (NPG), instrumentation and recapitulation will be strictly confined to the established working length, with no instrument intentionally passing beyond the apex. All procedures will be performed under standard endodontic protocols using rubber dam isolation, 2% lidocaine anesthesia, and 3% sodium hypochlorite irrigation. Postoperative pain severity will be self-assessed by patients using the 11-point Numerical Rating Scale (NRS) at 24 hours post-treatment. The primary outcome will be the presence or absence of pain, while secondary analysis will explore pain intensity categories (mild, moderate, severe)."
- Conditions
- Asymptomatic Irreversible Pulpitis
- Being tested
- Apical Patency Technique, Non-Patency Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apical Patency TechniqueProcedure or surgery
After each rotary instrument, a pre-curved #10 K-file was passively passed 0.5 mm beyond the working length. No filing motion was performed.
Non-Patency TechniqueProcedure or surgery
No instrument was intentionally passed beyond the working length. Recapitulation was performed only to the working length.
| Study group | Role | What they receive |
|---|---|---|
| Apical Patency Group | Experimental | Arm 1 - Apical Patency Group (APG) A #10 K-file is passed 0.5 mm beyond working length after each rotary instrument Receives: Procedure: Apical Patency Technique |
| Non-Patency Group | Active comparator | Arm 2 - Non-Patency Group (NPG) Recapitulation confined to working length only; no instrument passed beyond apex Receives: Procedure: Non-Patency Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Measure Presence of postoperative pain
Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)
Measured: 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start24 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Irreversible PulpitisStudies 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
- Model description
- Participants receive root canal treatment either with or without apical patency.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bolan Medical Complex Hospital Quetta Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misbah, Bolan Medical Complex Hospital Quetta Pakistan
- Investigators
- Dr Syed Attaullah Shah, BDS, Fcps, Study chair, Bolan medical College sandeman Provisional hospital Quetta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648862
- Sponsor's protocol ID
- BolanMed
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post Operative Pain With and Without Apical Patency Technique in Asymptomatic Irreversible Pulpitis Teeth
- ClinicalTrials.gov ID
- NCT07648862
- Acronym / sponsor ID
- BolanMed
- Conditions
- Asymptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bolan Medical Complex Hospital Quetta PakistanUniversity, hospital or other
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 15 Jun 2026 (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.
Primary Outcome - Measure Presence of postoperative pain Primary Outcome - Time Frame 24 hours post-treatment Primary Outcome - Description Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)
Detailed description
Apical patency is a root canal preparation technique in which a small flexible K-file is passively passed just beyond the apical foramen to maintain canal permeability and prevent apical debris accumulation. Although this method improves irrigation flow to the apical third and reduces the risk of canal blockage, ledge formation, and transportation, its association with postoperative pain remains debatable. This randomized clinical trial aims to compare the frequency of postoperative pain between two treatment protocols in patients with asymptomatic irreversible pulpitis involving maxillary or mandibular premolars. Participants will be randomly allocated into two equal groups. In the Apical Patency Group (APG), a pre-curved #10 K-file will be gently passed 0.5 mm beyond the radiographic working length after each rotary instrument, without filing motion. In the Non-Patency Group (NPG), instrumentation and recapitulation will be strictly confined to the established working length, with no instrument intentionally passing beyond the apex. All procedures will be performed under standard endodontic protocols using rubber dam isolation, 2% lidocaine anesthesia, and 3% sodium hypochlorite irrigation. Postoperative pain severity will be self-assessed by patients using the 11-point Numerical Rating Scale (NRS) at 24 hours post-treatment. The primary outcome will be the presence or absence of pain, while secondary analysis will explore pain intensity categories (mild, moderate, severe)."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive root canal treatment either with or without apical patency.
| Arm | Type | Receives |
|---|---|---|
| Apical Patency Group | Experimental | Procedure: Apical Patency TechniqueArm 1 - Apical Patency Group (APG) A #10 K-file is passed 0.5 mm beyond working length after each rotary instrument |
| Non-Patency Group | Active comparator | Procedure: Non-Patency TechniqueArm 2 - Non-Patency Group (NPG) Recapitulation confined to working length only; no instrument passed beyond apex |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Apical Patency TechniqueAfter each rotary instrument, a pre-curved #10 K-file was passively passed 0.5 mm beyond the working length. No filing motion was performed. | Procedure or surgery | Apical Patency Group |
| Non-Patency TechniqueNo instrument was intentionally passed beyond the working length. Recapitulation was performed only to the working length. | Procedure or surgery | Non-Patency Group |
Primary outcome
Primary Outcome - Measure Presence of postoperative pain
Time frame: 24 hours post-treatment
Postoperative pain assessed using the Numerical Rating Scale (NRS), categorized as present (NRS ≥1) or absent (NRS = 0)
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 26 Aug 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
Related trials for Asymptomatic Irreversible Pulpitis
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.
Dr Syed Attaullah Shah, BDS, Fcps study chair
Bolan medical College sandeman Provisional hospital Quetta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apical Patency Technique and Non-Patency Technique in people with Asymptomatic Irreversible Pulpitis, run by Bolan Medical Complex Hospital Quetta Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Aug 2026. 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 Pakistan. 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?
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 Dr. Misbah Principal Investigator, BDS FCPS (+92-334-1364014, khanmusbah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Measure Presence of postoperative pain (time frame: 24 hours post-treatment). 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 26 Aug 2026.