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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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 groups in NCT06972433
Study groupRoleWhat they receive
Single visit root canal treatmentExperimentalPatients 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 treatmentActive comparatorPatients 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.

  1. 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.

  1. First posted15 May 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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)
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

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.

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