NCT06732063

Brief Summary

The aim of this study is to compare the effects of two different working length determination methods on the incidence of postoperative pain in single-rooted, single-canal teeth undergoing root canal retreatment (RCR). Sixty-four previously treated, single-rooted, single-canal teeth, which were determined to require RCR based on clinical symptoms and radiographic findings, were randomly and equally divided into two groups and included in the study. Two distinct working mechanisms of an integrated endodontic motor with an apex locator were used in our study. One method involved simultaneous determination of the working length during canal shaping, while the other method determined the working length with a hand file after the canal filling was removed. After the session in which the methods were applied and the working length was determined, participants' pain levels were recorded using a visual analog scale (VAS) at 6-12 hours and on days 1-2-3-4-5-6-7.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

December 10, 2024

Last Update Submit

December 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of different working length measurement methods in endodontic treatment and postoperative pain.

    For the purpose of evaluating postoperative pain, the difference between two different working length measurement methods used during endodontic retreatment was analyzed. Postoperative pain was measured by visual analog scale (VAS) scores of the patients during the first 7 days after the procedure.

    7 days

Study Arms (2)

Separate length determination method

OTHER
Device: endodontic retreatment

Simultaneous length determination method

OTHER
Device: endodontic retreatment

Interventions

Re-treatment of previously failed root canal treatments

Separate length determination methodSimultaneous length determination method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers aged between 18 and 65 with no systemic diseases. Teeth without acute apical abscess. Single-rooted and single-canal teeth that have previously undergone root canal treatment, failed, and require re-treatment (diagnosed based on clinical symptoms and radiographic findings).
  • Individuals with preoperative pain rated 50 or lower on the 100 mm VAS scale

You may not qualify if:

  • Individuals with systemic diseases or allergic reactions. Pregnancy and breastfeeding. Teeth with open apex. Teeth with internal or external root resorption. Patients who have taken analgesic, anti-inflammatory, or antibiotic medications within the last twelve hours.
  • Teeth with broken instruments in the canal. Individuals with bruxism problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Talas, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

November 13, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations