- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526818
Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator.
Comparison of Mechanical and Manual Glide Path Techniques for Electronic Working Length Measurement Using Built-in or Standalone Apex Locator: A Randomized Controlled Trial.
This study is designed to compare two commonly used methods for measuring the length of the root canal during root canal treatment. Accurate measurement of the root canal is very important because it helps dentists clean, shape, and fill the canal properly, which improves the success of the treatment and reduces the risk of complications.
In this study, two different techniques will be evaluated. The first method uses small hand instruments (manual technique) to create a smooth pathway inside the root canal before measuring its length. The second method uses a machine-assisted system (mechanical technique) that creates this pathway automatically. Both methods use special electronic devices called apex locators, which help determine the exact length of the root canal more accurately than traditional X-rays alone.
Participants in this study will be patients who require root canal treatment on lower molar teeth. If you agree to take part, you will receive standard root canal treatment similar to routine dental care. The only difference is the method used to prepare the canal and measure its length, which will be randomly assigned. This means neither you nor the dentist will choose the method, ensuring fair comparison.
The procedure will include taking dental X-rays, administering local anesthesia, cleaning and shaping the root canal, and filling it after measurement. All steps follow standard dental practices and safety protocols. Your treatment will not be compromised in any way by participating in the study.
The purpose of this research is to determine which method is more accurate, efficient, and reliable. The results may help improve future dental treatments by guiding dentists toward better techniques, ultimately benefiting patients through safer and more effective care.
Participation in this study is completely voluntary. You have the right to refuse participation or withdraw at any time without affecting your dental treatment. All personal and medical information will be kept confidential and used only for research purposes.
There are minimal risks involved, as all procedures are part of routine root canal treatment. You may not receive direct personal benefit, but your participation will contribute to improving dental care for others in the future.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75600
- Dow University Of health Sciences.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both sex.
- Aged 18 to 60 years.
- Lower first permanent molars seeking root canal treatment.
- Teeth exhibiting symptomatic irreversible pulpitis with normal periapical tissues.
- Teeth with mature apex.
3 visible canals from orifice to apex.
-
Exclusion Criteria:
- Teeth with metallic restorations or previous root treated teeth.
- Fractured , teeth with immature apices, or developmental anomalies.
- Systemic disease and immune deficiency.
- Canals where the mechanical glide path could not be established.
- Teeth with canal calcification or root resorption.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1: Control
Group 1( Control): ): Manual glide path with size 10 K-file, working length determined by Root ZX II, confirmed radiographically.
|
Manual glide path with size 10 K-file, working length determined by Root ZX II, confirmed radiographically.
|
|
Experimental: Group 2: Intervention
Group 2 (Intervention): Mechanical glide path using E-connect S+ with auto apical stop function, confirmed radiographically
|
Creating Mechanical glide path using E-connect S+ with auto apical stop function, confirmed radiographically
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electronic working length (in millimeters) of root canals
Time Frame: 1 hour.
|
The primary outcome measure is the electronic working length (in millimeters) of root canals as determined by either a standalone apex locator or an endomotor with built-in apex locator, following manual or mechanical glide path preparation.
|
1 hour.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB4481/DUHS/Approval/2026/113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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