Comparative Evaluation of Impact of Sodium Hypochlorite on the Physical Properties of Protaper Gold and Dia-X ProTaper.
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of the endodontic treatment is to make the root canal system free of the bacteria and its products to maximum extent, to allow healing of the inflamed apical periodontium. Nickel titanium files have super elasticity, better cutting efficiency, and shapes canal anatomy more efficiently as compared to stainless steel manual files. Regardless of these properties, main shortcoming of Ni-Ti based files is their tendency to fracture unexpectedly inside the root canals. This abrupt file separation could be due to mechanical friction or chemical stimuli leading to the damage of surface contents (wear) and formation of micro cracks, waviness, scratches or roughness. Sodium Hypochlorite is considered a gold standard irrigant in endodontics that renders bacteria free root canal system, but it has been postulated to have many shortcomings and certain concentrations of Sodium Hypochlorite affects the properties of Ni-Ti rotary instruments. This clinical trial aimed to compare the physical properties (dimensional stability, deformation, surface roughness and metal slivering) and impact of 5.25% sodium hypochlorite on these physical properties of Protaper Gold finishing F2 Files and Dia-X ProTaper finishing D4 files when subjected to root canal preparation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedApril 5, 2022
April 1, 2022
4 years
December 8, 2021
April 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Stereomicroscope and Optical microscope used to evaluate the changes of finishing files of ProTaper Gold (F2) and Dia-X ProTaper (D4).
The change in dimensional stability of two file systems before and after clinical application and after exposure to Sodium Hypochlorite in root canal system.
9 Months
Stereomicroscope and Optical microscope used to evaluate the changes of finishing files of ProTaper Gold (F2) and Dia-X ProTaper (D4).
The change in surface roughness of two file systems before and after clinical application and after exposure to Sodium Hypochlorite in root canal system.
9 months.
Stereomicroscope and Optical microscope used to evaluate the changes of finishing files of ProTaper Gold (F2) and Dia-X ProTaper (D4).
The change in Deformation of two file systems before and after clinical application and after exposure to Sodium Hypochlorite in root canal system.
9 months
Stereomicroscope and Optical microscope used to evaluate monitor the changes of finishing files of ProTaper Gold (F2) and Dia-X ProTaper (D4).
The Presence or absence of metal slivering of two file systems before and after clinical application and after exposure to Sodium Hypochlorite in root canal system.
9 months
Study Arms (4)
ProTaper Gold (F2) - NaOCL
EXPERIMENTALProTaper Files without NaOCL
ProTaper Gold (F2) + NaOCL
EXPERIMENTALProTaper Files with NaOCL
Dia-X ProTaper (D4) - NaOCL
EXPERIMENTALDia-X ProTaper (D4) without NaOCL
Dia-X ProTaper (D4) + NaOCL
EXPERIMENTALDia-X ProTaper (D4) with NaOCL
Interventions
Finishing files of ProTaper Gold (F2) without effect to NaOCL
Finishing files of ProTaper Gold (F2) with effect to NaOCL
Finishing files of Dia-X ProTaper (D4) without effect to NaOCL
Finishing files of Dia-X ProTaper (D4) without effect to NaOCL
Eligibility Criteria
You may qualify if:
- Mandibular first permanent molars
- A degree of root canal curvature ranging from 10 to 20 degree taper.
You may not qualify if:
- Teeth with internal and external resorption
- Teeth with calcified canals
- Previously endodontic treated teeth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dow university of Health Sciences
Karachi, Sindh, Pakistan
Related Publications (1)
Zinelis S, Eliades T, Eliades G. A metallurgical characterization of ten endodontic Ni-Ti instruments: assessing the clinical relevance of shape memory and superelastic properties of Ni-Ti endodontic instruments. Int Endod J. 2010 Feb;43(2):125-34. doi: 10.1111/j.1365-2591.2009.01651.x.
PMID: 20078701RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iqra Kamal, BDS
Dow University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer/ MDS Post graduate trainee
Study Record Dates
First Submitted
December 8, 2021
First Posted
April 5, 2022
Study Start
January 1, 2018
Primary Completion
December 20, 2021
Study Completion
January 15, 2022
Last Updated
April 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share