Comparison of Endodontic Flare up in Single Visit Root Canal Treatment Versus Multiple Visit Root Canal Treatment in Patients Visiting Scd, Swat.

NCT06972433 | Not Yet Recruiting

• 1 other identifier: 106-ERB/024
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Postoperative Complication; Root Canal Therapy; Pulpitis - Irreversible

Keywords

enddoontic flare-ups, root canal therapy, single visit root canal treatment, multiple visit root canal treatment

Outcome Measures

Primary Outcomes (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

  With in 48 hours after root canal treatment

Study Arms (2)

Single visit root canal treatment

EXPERIMENTAL

Patients receive complete root canal therapy in a single appointment, including cleaning, shaping, and obturation of canals.

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.

Procedure: Multiple visit root canal treatment

Interventions

single visit root canal treatment PROCEDURE

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.

Single visit root canal treatment

Multiple visit root canal treatment PROCEDURE

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.

Multiple visit root canal treatment

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

Related Links

• 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 .

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Warisha Ubaid

  Saidu College of Dentistry Swat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warisha Ubaid

CONTACT

+923459686870; wareeshah.ubaid@yahoo.com

Fahim Ullah

CONTACT

+923018092160; drfahimullah1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participant will be blinded to the group assignment (single-visit vs. multiple-visit root canal treatment). The care provider and investigator will be aware of the allocation due to procedural differences. Blinding of participants is maintained by not informing them about the number of treatment visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: trainee medical officer at saidu college of dentistry ,swat

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share