Accuracy of ERCLMDs in Teeth With Apical Periodontitis

Phase 1

Completed

• Conditions: Apical Periodontitis
• Interventions: Device: Electronic Root Canal Length Measurement Device

• Registration Number: NCT01904552
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement devices.

Detailed Description

Thirty-two single-rooted teeth scheduled for extraction, consisting of 16 teeth with AP and 16 teeth with normal periapex (NP), were selected. Access cavity was prepared and coronal portion of the canal was flared. Electronic working length (EWL) was determined by each ERCLMD according to each manufacturer's instructions. Each tooth was extracted and actual working length (AWL) was determined by inserting a size 15 K-file until the tip could be seen at a position tangential to the major foramen and then 0.5 mm was subtracted from the measurement. The distance from the AWL to the file tip was calculated and compared between the two groups by t-test. The accuracy of each ERCLMD within ±0.5 mm was compared between the groups by Fisher's test. Statistical significance was set at P \< .05.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-17
• Last Update Submitted: 2013-07-17
• Study First Posted: 2013-07-22
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• single-rooted teeth
• clinical pulp necrosis and periapical index scores of 3, 4 or 5
• pulp vitality and a periapical index score of 1

Exclusion Criteria

• Teeth with metal restorations
• Teeth with prosthetic crowns
• Teeth with pulp calcification
• Teeth with previous endodontic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
apical periodontitis (AP)	Electronic Root Canal Length Measurement Device	clinical pulp necrosis periapical index scores of 3, 4 or 5
normal periapex (NP)	Electronic Root Canal Length Measurement Device	clinical pulp vitality periapical index score of 1

Primary Outcome Measures

Name	Time	Method
Actual working length (AWL)	6 months

Secondary Outcome Measures

Name	Time	Method
Electronic working length (EWL)	6 months

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of