Achievement of Working Length After Manual Versus Mechanical Glide PathNCT07612228
Effect of Manual and Mechanical Glide Path Preparation on Working Length Accuracy.
A study testing Manual Glide Path Preparation and Mechanical Glide Path Preparation in people with Achievement of Working Length After Manual Versus Mechanical Glide Path, run by Pakistan Institute of Medical Sciences.
Trial summary
Accurate working length determination is essential for successful root canal treatment and is influenced by proper glide path preparation. This in vitro study aims to compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Achievement of Working Length After Manual Versus Mechanical Glide Path
- What is being tested?
- Manual Glide Path Preparation and Mechanical Glide Path Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2026to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Extracted permanent single-rooted teeth. Teeth with fully formed mature apices. Teeth with intact roots and no structural defects. Root canals with curvature less than 15 degrees. Teeth with patent canals allowing negotiation with a size #10 K-file.
Who cannot join
- Teeth with caries, fractures, cracks, or root defects. Teeth with previous endodontic treatment. Teeth showing root resorption or calcified canals. Teeth with unusual root canal anatomy or multiple canals. Teeth with severe canal curvature greater than 15 degrees. Teeth with immature apices or open apices.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alina Malik, BDS contact
About this study
Official title: Comparison of Working Length Accuracy Following Manual and Mechanical Glide Path Preparation: An In Vitro Study.
Accurate working length determination is essential for successful root canal treatment and is influenced by proper glide path preparation. This in vitro study aims to compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques. Sixty extracted single-rooted permanent teeth will be randomly allocated into two groups. Group 1 will undergo manual glide path preparation using stainless steel K-files, while Group 2 will receive mechanical glide path preparation using rotary PathFile instruments. Initial and final working lengths will be measured using an electronic apex locator and confirmed with digital radiographs. The difference between the initial and final working lengths will be analyzed statistically. The results of this study will help identify the more effective glide path preparation technique for maintaining working length accuracy and improving endodontic treatment outcomes.
Read the detailed description
This study is an in vitro randomized controlled experimental investigation designed to evaluate and compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques during root canal treatment.
A total of 60 extracted single-rooted permanent teeth with intact roots, mature apices, and minimal canal curvature (≤15°) will be selected according to predefined inclusion and exclusion criteria. After disinfection and sterilization, the teeth will be mounted in resin blocks to ensure stability during instrumentation. The samples will then be randomly allocated into two equal groups (n = 30 each) using a computer-generated randomization method.
Standard access cavities will be prepared for all samples. Canal patency and initial working length will be determined using an electronic apex locator and confirmed with digital periapical radiographs. Silicone stoppers will be used to standardize reference points for all measurements.
In Group 1 (manual glide path group), glide path preparation will be performed using a size #10 stainless steel K-file with a watch-winding and gentle filing motion. In Group 2 (mechanical glide path group), glide path preparation will be carried out using rotary PathFile instruments in sequence with an engine-driven handpiece, following the manufacturer's recommendations. All procedures will be performed by a single operator to eliminate operator-related variability.
After completion of glide path preparation and canal shaping, the final working length will be re-determined using the same apex locator and radiographic methods. The difference between the initial and final working lengths will be measured in millimeters for each specimen and recorded as the primary outcome variable.
Statistical analysis will be performed using SPSS software. Descriptive statistics (mean and standard deviation) will be calculated, and inferential analysis will include paired t-tests for within-group comparisons and independent t-tests for between-group comparisons, with a significance level set at p < 0.05.
The results of this study are expected to provide evidence regarding which glide path preparation technique better preserves working length accuracy, thereby assisting clinicians in selecting optimal endodontic instrumentation protocols and improving treatment outcomes.
- Being tested
- Manual Glide Path Preparation, Mechanical Glide Path Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Glide Path PreparationProcedure or surgery
Glide path is created using stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth path from the canal orifice to the apex.
Mechanical Glide Path PreparationProcedure or surgery
Glide path is created using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following manufacturer instructions to establish a smooth path from the canal orifice to the apex.
| Study group | Role | What they receive |
|---|---|---|
| Manual Glide Path Preparation | Experimental | Teeth in this arm will undergo glide path preparation using manual stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth glide path up to the predetermined working length. Receives: Procedure: Manual Glide Path Preparation |
| Mechanical Glide Path Preparation | Active comparator | Teeth in this arm will undergo glide path preparation using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following the manufacturer's instructions to establish the glide path up to the predetermined working length. Receives: Procedure: Mechanical Glide Path Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of working length achievement in mm
The primary outcome of this study will be the accuracy of working length achievement after glide path preparation using manual and mechanical techniques. It will be assessed by measuring the difference between the initial working length (recorded before instrumentation) and the final working length (recorded after glide path preparation and canal shaping) in millimeters. Working length measurements will be obtained using an apex locator and confirmed with digital periapical radiographs. A smaller difference between the initial and final working lengths will indicate better maintenance and achievement of the accurate working length.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start4 Oct 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achievement of Working Length After Manual Versus Mechanical Glide PathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aleena Malik, Pakistan Institute of Medical Sciences
- Investigators
- Aleena Malik, BDS, Principal investigator, PakistanAlina Malik, Principal investigator, School Of Dentistry,Shaheed Zulfiqar Ali Bhutto Medical University,Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612228
- Sponsor's protocol ID
- SOD/ERB/2025/72
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Working Length Accuracy Following Manual and Mechanical Glide Path Preparation: An In Vitro Study.
- ClinicalTrials.gov ID
- NCT07612228
- Acronym / sponsor ID
- SOD/ERB/2025/72
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 4 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accurate working length determination is essential for successful root canal treatment and is influenced by proper glide path preparation. This in vitro study aims to compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques. Sixty extracted single-rooted permanent teeth will be randomly allocated into two groups. Group 1 will undergo manual glide path preparation using stainless steel K-files, while Group 2 will receive mechanical glide path preparation using rotary PathFile instruments. Initial and final working lengths will be measured using an electronic apex locator and confirmed with digital radiographs. The difference between the initial and final working lengths will be analyzed statistically. The results of this study will help identify the more effective glide path preparation technique for maintaining working length accuracy and improving endodontic treatment outcomes.
Detailed description
This study is an in vitro randomized controlled experimental investigation designed to evaluate and compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques during root canal treatment.
A total of 60 extracted single-rooted permanent teeth with intact roots, mature apices, and minimal canal curvature (≤15°) will be selected according to predefined inclusion and exclusion criteria. After disinfection and sterilization, the teeth will be mounted in resin blocks to ensure stability during instrumentation. The samples will then be randomly allocated into two equal groups (n = 30 each) using a computer-generated randomization method.
Standard access cavities will be prepared for all samples. Canal patency and initial working length will be determined using an electronic apex locator and confirmed with digital periapical radiographs. Silicone stoppers will be used to standardize reference points for all measurements.
In Group 1 (manual glide path group), glide path preparation will be performed using a size #10 stainless steel K-file with a watch-winding and gentle filing motion. In Group 2 (mechanical glide path group), glide path preparation will be carried out using rotary PathFile instruments in sequence with an engine-driven handpiece, following the manufacturer's recommendations. All procedures will be performed by a single operator to eliminate operator-related variability.
After completion of glide path preparation and canal shaping, the final working length will be re-determined using the same apex locator and radiographic methods. The difference between the initial and final working lengths will be measured in millimeters for each specimen and recorded as the primary outcome variable.
Statistical analysis will be performed using SPSS software. Descriptive statistics (mean and standard deviation) will be calculated, and inferential analysis will include paired t-tests for within-group comparisons and independent t-tests for between-group comparisons, with a significance level set at p < 0.05.
The results of this study are expected to provide evidence regarding which glide path preparation technique better preserves working length accuracy, thereby assisting clinicians in selecting optimal endodontic instrumentation protocols and improving treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Glide Path Preparation | Experimental | Procedure: Manual Glide Path PreparationTeeth in this arm will undergo glide path preparation using manual stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth glide path up to the predetermined working length. |
| Mechanical Glide Path Preparation | Active comparator | Procedure: Mechanical Glide Path PreparationTeeth in this arm will undergo glide path preparation using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following the manufacturer's instructions to establish the glide path up to the predetermined working length. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Extracted permanent single-rooted teeth. Teeth with fully formed mature apices. Teeth with intact roots and no structural defects. Root canals with curvature less than 15 degrees. Teeth with patent canals allowing negotiation with a size #10 K-file.
Key exclusion criteria (1 listed)
- Teeth with caries, fractures, cracks, or root defects. Teeth with previous endodontic treatment. Teeth showing root resorption or calcified canals. Teeth with unusual root canal anatomy or multiple canals. Teeth with severe canal curvature greater than 15 degrees. Teeth with immature apices or open apices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Glide Path PreparationGlide path is created using stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth path from the canal orifice to the apex. | Procedure or surgery | Manual Glide Path Preparation |
| Mechanical Glide Path PreparationGlide path is created using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following manufacturer instructions to establish a smooth path from the canal orifice to the apex. | Procedure or surgery | Mechanical Glide Path Preparation |
Primary outcome
Accuracy of working length achievement in mm
Time frame: Six months
The primary outcome of this study will be the accuracy of working length achievement after glide path preparation using manual and mechanical techniques. It will be assessed by measuring the difference between the initial working length (recorded before instrumentation) and the final working length (recorded after glide path preparation and canal shaping) in millimeters. Working length measurements will be obtained using an apex locator and confirmed with digital periapical radiographs. A smaller difference between the initial and final working lengths will indicate better maintenance and achievement of the accurate working length.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alina Malik, BDS contact
Aleena Malik, BDS principal investigator
Pakistan
Alina Malik principal investigator
School Of Dentistry,Shaheed Zulfiqar Ali Bhutto Medical University,Islamabad
Questions about this trial
What is this clinical trial studying?
A study testing Manual Glide Path Preparation and Mechanical Glide Path Preparation in people with Achievement of Working Length After Manual Versus Mechanical Glide Path, run by Pakistan Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Malik, BDS (+923049579435, alinamalik32198@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of working length achievement in mm (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.