Postoperative ComplicationNCT06972433
Comparison of Endodontic Flare up in Single Visit Root Canal Treatment Versus Multiple Visit Root Canal Treatment in Patients Visiting Scd, Swat.
A study testing single visit root canal treatment and Multiple visit root canal treatment in people with Postoperative Complication and Root Canal Therapy, run by College of Physicians and Surgeons Pakistan.
Trial summary
This randomized controlled trial aims to compare the incidence of endodontic flare-ups in patients undergoing single-visit versus multiple-visit root canal treatment (RCT) at Saidu College of Dentistry, Swat. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Postoperative Complication, Root Canal Therapy, Pulpitis - Irreversible
- What is being tested?
- single visit root canal treatment and Multiple visit root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children in the age group >10 years with deep caries approximating pulp on radiograph and indicated for a root canal treatment.
- Proper bone support.
- No evidence of severe mobility/discharge of frank pus
- Radiographically tooth indicated for root canal treatment.
- Permanent first molars with periapical radiolucency not exceeding 3 mm × 3 mm in size.
- Complete root formation.
- Teeth in which the initial master file (K-File)binds at the apex were of ISO size 45 or less.
Who cannot join
- Tooth/teeth with extensive periodontal pathology/ periapical radiolucency.
- Teeth with evidence of internal or external root resorption involving more than one third of the root length.
- Children with facial cellulitis or significant extraoral swelling.
- Patients with any systemic diseases.
- Patients who had been taking Antibiotics ,nonsteroidal anti-inflammatory drugs, corticosteroids at time of treatment.
- Pregnant patients
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
This randomized controlled trial aims to compare the incidence of endodontic flare-ups in patients undergoing single-visit versus multiple-visit root canal treatment (RCT) at Saidu College of Dentistry, Swat. The study will recruit 344 patients aged above 10 and below 60 years, with permanent first molars indicated for RCT and meeting specific clinical and radiographic criteria. Participants will be randomly allocated into two groups: one receiving single-visit RCT and the other receiving multiple-visit RCT. Pain and flare-up incidence will be evaluated using the Visual Analog Scale (VAS) and swelling grading criteria at 6, 24, and 48 hours post-treatment. The primary outcome is the frequency of endodontic flare-ups requiring additional intervention. The study also examines the role of occlusal reduction in managing postoperative discomfort. Data will be analyzed using SPSS v23 with chi-square and Fisher's exact tests to compare outcomes. The findings aim to inform evidence-based protocols for endodontic treatment in the local population.
Read the detailed description
This randomized controlled trial is designed to compare the frequency of endodontic flare-ups following single-visit versus multiple-visit root canal treatment in patients presenting to Saidu College of Dentistry, Swat. An endodontic flare-up is defined as a significant postoperative complication characterized by unexpected severe pain and/or swelling occurring within hours to a few days after treatment and requiring unscheduled clinical intervention. The study will include 344 patients aged above 10 and below 60 years, with deep caries and symptomatic irreversible pulpitis or symptomatic apical periodontitis in permanent first molars. All selected teeth will have complete root formation and periapical radiolucencies not exceeding 3x3 mm. Patients with systemic diseases, pregnancy, current or recent use of antibiotics, NSAIDs or corticosteroids, facial cellulitis, severe mobility, frank pus discharge, or significant root resorption will be excluded. The sample size is calculated using WHO sample size calculator with 80% power, 5% margin of error, and expected flare-up proportions of 18.3% for single-visit and 8.1% for multiple-visit groups based on prior research. Patients meeting inclusion criteria will be selected through purposive non-probability sampling and randomly assigned into two groups (single-visit and multiple-visit) using a lottery method. All patients will undergo a standardized treatment protocol including local anesthesia with 2% lidocaine and 1:100,000 epinephrine, rubber dam isolation, access preparation, canal irrigation with 5.25% sodium hypochlorite, and biomechanical preparation using ProTaper Universal rotary files. Working length will be determined using a Woodpecker apex locator and confirmed with radiographs. Apical patency will be maintained using a #10 K-file, and the apical width will be prepared three sizes larger than the initial binding file.
In the single-visit group, cleaning, shaping, and obturation will be completed in the same appointment, followed by restoration with light-cured glass ionomer cement. In the multiple-visit group, cleaning and shaping will be completed in the first appointment with medicament placement, and obturation will be performed in a subsequent visit. All canals will be obturated using the cold lateral compaction technique with gutta-percha and Kerr Sealapex sealer. After treatment, a final periapical radiograph will be taken. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 24, and 48 hours post-treatment. Swelling will be graded on a 0-3 scale. A flare-up will be recorded if the patient reports pain ≥7 on the VAS or swelling grade ≥2 requiring analgesics or emergency care. Patients will be contacted via phone for pain monitoring, and instructed to report any sudden worsening of symptoms. Data will be recorded in a structured proforma.
The primary outcome measure is the incidence of endodontic flare-ups within 48 hours post-treatment. Secondary outcomes include postoperative pain intensity and need for unscheduled care. Data analysis will be conducted using SPSS v23. Mean and standard deviation will be calculated for continuous variables like age, and frequency and percentages for categorical variables like gender and flare-up incidence. The chi-square test will be used to compare flare-up rates between groups. Stratification will be done by age and gender to identify effect modifiers, and post-stratification chi-square or Fisher's exact test will be used as appropriate. A p-value of <0.05 will be considered statistically significant. The study aims to address the current gap in local literature regarding endodontic flare-ups in the Khyber Pakhtunkhwa population and evaluate the effectiveness of treatment protocols for better pain management in routine dental practice.
- Being tested
- single visit root canal treatment, Multiple visit root canal treatment
- Keywords
- enddoontic flare-ups, root canal therapy, single visit root canal treatment, multiple visit root canal treatment
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single visit root canal treatmentProcedure or surgery
Root canal procedure performed in a single visit using ProTaper file system, sodium hypochlorite irrigation, and lateral compaction with gutta-percha and sealer. Final restoration with GIC.
Multiple visit root canal treatmentProcedure or surgery
Root canal procedure performed over two or more visits using the same instrumentation and irrigation protocol. Canals are medicated between appointments before obturation and restoration.
| Study group | Role | What they receive |
|---|---|---|
| Single visit root canal treatment | Experimental | Patients receive complete root canal therapy in a single appointment, including cleaning, shaping, and obturation of canals. Receives: Procedure: single visit root canal treatment |
| Multiple visit root canal treatment | Active comparator | Patients receive root canal therapy over multiple appointments, with canal medication between visits before final obturation. Receives: Procedure: Multiple visit root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of endodontic flare-ups
Flare-up defined as severe postoperative pain (VAS score ≥ 7) and/or swelling requiring unscheduled dental intervention, excluding pre-existing conditions
Measured: With in 48 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warisha Ubaid, College of Physicians and Surgeons Pakistan
- Investigators
- Warisha Ubaid, Principal investigator, Saidu College of Dentistry Swat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972433
- Sponsor's protocol ID
- 106-ERB/024
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endodontic Flare up in Single Visit Root Canal Treatment Versus Multiple Visit Root Canal Treatment in Patients Visiting Scd, Swat.
- ClinicalTrials.gov ID
- NCT06972433
- Acronym / sponsor ID
- 106-ERB/024
- Keywords
- enddoontic flare-ups, root canal therapy, single visit root canal treatment, multiple visit root canal treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 May 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 aims to compare the incidence of endodontic flare-ups in patients undergoing single-visit versus multiple-visit root canal treatment (RCT) at Saidu College of Dentistry, Swat. The study will recruit 344 patients aged above 10 and below 60 years, with permanent first molars indicated for RCT and meeting specific clinical and radiographic criteria. Participants will be randomly allocated into two groups: one receiving single-visit RCT and the other receiving multiple-visit RCT. Pain and flare-up incidence will be evaluated using the Visual Analog Scale (VAS) and swelling grading criteria at 6, 24, and 48 hours post-treatment. The primary outcome is the frequency of endodontic flare-ups requiring additional intervention. The study also examines the role of occlusal reduction in managing postoperative discomfort. Data will be analyzed using SPSS v23 with chi-square and Fisher's exact tests to compare outcomes. The findings aim to inform evidence-based protocols for endodontic treatment in the local population.
Detailed description
This randomized controlled trial is designed to compare the frequency of endodontic flare-ups following single-visit versus multiple-visit root canal treatment in patients presenting to Saidu College of Dentistry, Swat. An endodontic flare-up is defined as a significant postoperative complication characterized by unexpected severe pain and/or swelling occurring within hours to a few days after treatment and requiring unscheduled clinical intervention. The study will include 344 patients aged above 10 and below 60 years, with deep caries and symptomatic irreversible pulpitis or symptomatic apical periodontitis in permanent first molars. All selected teeth will have complete root formation and periapical radiolucencies not exceeding 3x3 mm. Patients with systemic diseases, pregnancy, current or recent use of antibiotics, NSAIDs or corticosteroids, facial cellulitis, severe mobility, frank pus discharge, or significant root resorption will be excluded. The sample size is calculated using WHO sample size calculator with 80% power, 5% margin of error, and expected flare-up proportions of 18.3% for single-visit and 8.1% for multiple-visit groups based on prior research. Patients meeting inclusion criteria will be selected through purposive non-probability sampling and randomly assigned into two groups (single-visit and multiple-visit) using a lottery method. All patients will undergo a standardized treatment protocol including local anesthesia with 2% lidocaine and 1:100,000 epinephrine, rubber dam isolation, access preparation, canal irrigation with 5.25% sodium hypochlorite, and biomechanical preparation using ProTaper Universal rotary files. Working length will be determined using a Woodpecker apex locator and confirmed with radiographs. Apical patency will be maintained using a #10 K-file, and the apical width will be prepared three sizes larger than the initial binding file.
In the single-visit group, cleaning, shaping, and obturation will be completed in the same appointment, followed by restoration with light-cured glass ionomer cement. In the multiple-visit group, cleaning and shaping will be completed in the first appointment with medicament placement, and obturation will be performed in a subsequent visit. All canals will be obturated using the cold lateral compaction technique with gutta-percha and Kerr Sealapex sealer. After treatment, a final periapical radiograph will be taken. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 24, and 48 hours post-treatment. Swelling will be graded on a 0-3 scale. A flare-up will be recorded if the patient reports pain ≥7 on the VAS or swelling grade ≥2 requiring analgesics or emergency care. Patients will be contacted via phone for pain monitoring, and instructed to report any sudden worsening of symptoms. Data will be recorded in a structured proforma.
The primary outcome measure is the incidence of endodontic flare-ups within 48 hours post-treatment. Secondary outcomes include postoperative pain intensity and need for unscheduled care. Data analysis will be conducted using SPSS v23. Mean and standard deviation will be calculated for continuous variables like age, and frequency and percentages for categorical variables like gender and flare-up incidence. The chi-square test will be used to compare flare-up rates between groups. Stratification will be done by age and gender to identify effect modifiers, and post-stratification chi-square or Fisher's exact test will be used as appropriate. A p-value of <0.05 will be considered statistically significant. The study aims to address the current gap in local literature regarding endodontic flare-ups in the Khyber Pakhtunkhwa population and evaluate the effectiveness of treatment protocols for better pain management in routine dental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single visit root canal treatment | Experimental | Procedure: single visit root canal treatmentPatients receive complete root canal therapy in a single appointment, including cleaning, shaping, and obturation of canals. |
| Multiple visit root canal treatment | Active comparator | Procedure: Multiple visit root canal treatmentPatients receive root canal therapy over multiple appointments, with canal medication between visits before final obturation. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children in the age group >10 years with deep caries approximating pulp on radiograph and indicated for a root canal treatment.
- Proper bone support.
- No evidence of severe mobility/discharge of frank pus
- Radiographically tooth indicated for root canal treatment.
- Permanent first molars with periapical radiolucency not exceeding 3 mm × 3 mm in size.
Key exclusion criteria (6 listed)
- Tooth/teeth with extensive periodontal pathology/ periapical radiolucency.
- Teeth with evidence of internal or external root resorption involving more than one third of the root length.
- Children with facial cellulitis or significant extraoral swelling.
- Patients with any systemic diseases.
- Patients who had been taking Antibiotics ,nonsteroidal anti-inflammatory drugs, corticosteroids at time of treatment.
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 |
|---|---|---|
| single visit root canal treatmentRoot canal procedure performed in a single visit using ProTaper file system, sodium hypochlorite irrigation, and lateral compaction with gutta-percha and sealer. Final restoration with GIC. | Procedure or surgery | Single visit root canal treatment |
| Multiple visit root canal treatmentRoot canal procedure performed over two or more visits using the same instrumentation and irrigation protocol. Canals are medicated between appointments before obturation and restoration. | Procedure or surgery | Multiple visit root canal treatment |
Primary outcome
Incidence of endodontic flare-ups
Time frame: With in 48 hours after root canal treatment
Flare-up defined as severe postoperative pain (VAS score ≥ 7) and/or swelling requiring unscheduled dental intervention, excluding pre-existing conditions
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 15 May 2025.
- This randomized controlled trail compares the incidence of endodontic flare ups (pain/swelling)between single visit and multiple visit root canal treatment.This study conducted at Saidu College of Dentistry,Swat, monitors patients over 6months .Link provided by the sponsor.
- 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.
Warisha Ubaid principal investigator
Saidu College of Dentistry Swat
Questions about this trial
What is this clinical trial studying?
A study testing single visit root canal treatment and Multiple visit root canal treatment in people with Postoperative Complication and Root Canal Therapy, 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 7 inclusion and 6 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 15 May 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 Warisha Ubaid (+923459686870, wareeshah.ubaid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of endodontic flare-ups (time frame: With in 48 hours after root canal 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 15 May 2025.