Evaluation of Post-operative Pain During Retreatment in Different Visits

NCT07014228 | Completed DMC

• 1 other identifier: Re-endo pain comparison
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Endodontic retreatment is performed to alleviate symptoms of recurring infection, post-treatment disease after primary endodontic therapy. Retreatment can be performed in either single or multiple visits. and have their own implications. it is important to compare the patient response and post-op pain after single vs multi-visit reendo treatment.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Post operative pain after re-endo

  Post-operative pain after single vs multi visit re-endo treatment to be compared. The patients will be guided in detail about the procedure and how to document their response to the treatment. The Visual Analog Scale (VAS). numbered from 0-10, with 0 being no pain, 1 - 3: mild pain, 4-6: moderate pain, and 7-10 severe pain, will be used to record pain experienced by the patients and notified to the investigator.

  6 hours - 72 hours

Study Arms (2)

Single visit group

EXPERIMENTAL

Endodontic retreatment in this group will be performed in a single visit. Initiated, deobturated, disinfection done and completed during the same visit.

Procedure: single visit re-endo

Multi visit Group

ACTIVE COMPARATOR

Endodontic retreatment in this group will be performed in more than 1 visit. The retreatment will be initiated, deobturated, and disinfection done and completed in second or third visits..

Procedure: multi visit re-endo

Interventions

single visit re-endo PROCEDURE

In this group, a single visit re-endodontic treatment will be performed and completed in the same visit, including all the steps.

Single visit group

multi visit re-endo PROCEDURE

In this group, a multi-visit re-endodontic treatment will be performed and completed over different visits, including all the steps.

Multi visit Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unremarkable/ noncontributory medical history
• Age range between 15-45 years
• Cases of failed endodontic treatment resulting from inadequate root filling
• No systemic disease
• No periodontal disease

You may not qualify if:

• Patients having teeth with periodontal pathology
• root fractures
• Immature root apices
• Endodontic posts
• Root perforations
• Immunocompromised health were excluded from the study.

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute of dentistry

Rawalpindi, Punjab Province, 64000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be divided into two equal groups and given two different interventions (single vs. multi-visit reendo).

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: April 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)