Back to resultsSuccess Rates for Management of Separated Instruments
Primary Purpose
Teeth, Endodontically-Treated
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endodontic retreatment
Sponsored by
About this trial
This is an interventional treatment trial for Teeth, Endodontically-Treated
Eligibility Criteria
Inclusion Criteria:
- Presence of separated instrument in a root with a Vertucci's type II configuration (the level of the SI was evaluated using CBCT scans)
- Age range 35-55 years
- Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root
Exclusion Criteria:
• Patients who refused to undergo radiographic follow-up.
- Pregnant females.
- Patients suffered from a systemic disease.
- Teeth with lesions connected to adjacent teeth.
- Teeth with root fractures or perforations.
- Teeth with lesion communicating with the alveolar crest.
- patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
- teeth with damaged or resorbed peri- apex
- teeth that were treated with a fiber post and teeth with canal curvature more than 25 degrees
Sites / Locations
- Faculty of Dentistry, Ainshams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
conservative treatment
traditional
Arm Description
The patent canal is retreated, no attempt to deal with the separated instrument
All canals are retreated with attempts to retrieve the broken file
Outcomes
Primary Outcome Measures
monitoring of periapical index
The peri-radicular condition was evaluated using the Periapical Index (PAI) created by Ørstavik et al. (1986). The PAI includes five grades represented on an ordinal scale as follows: (1) normal periapical structures; (2) small changes in the periapical bone or bone structure; (3) changes in the periapical bone structure with mineral loss, characteristic of apical periodontitis; (4) demineralization of the periapical bone within a well-defined radiolucent area; and (5) demineralization of the periapical bone with exacerbations and expansion in bone structure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05342246
Brief Title
Success Rates for Management of Separated Instruments
Official Title
Success Rates for Management of Separated Instruments in Canals With Type II Vertucci's Classification: Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach
Detailed Description
Teeth with Type II Vertucci root canal configuration are having more incidence of instruments separation due the presence of an S-type (Double curve). The aim of this study is to compare the outcome of minimally invasive approach (MIA), retaining the separated in one root canal, cleaning and shaping of portals of entry of the two canals and portal of exit of both canals through the other patent canal, in comparison to the outcome of retrieval of the broken instrument by ultrasonics retrieval techniques (URT)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth, Endodontically-Treated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conservative treatment
Arm Type
Experimental
Arm Description
The patent canal is retreated, no attempt to deal with the separated instrument
Arm Title
traditional
Arm Type
Active Comparator
Arm Description
All canals are retreated with attempts to retrieve the broken file
Intervention Type
Procedure
Intervention Name(s)
Endodontic retreatment
Intervention Description
retreatment of the patent root canal only without attempt to retrieve the separated instrument
Primary Outcome Measure Information:
Title
monitoring of periapical index
Description
The peri-radicular condition was evaluated using the Periapical Index (PAI) created by Ørstavik et al. (1986). The PAI includes five grades represented on an ordinal scale as follows: (1) normal periapical structures; (2) small changes in the periapical bone or bone structure; (3) changes in the periapical bone structure with mineral loss, characteristic of apical periodontitis; (4) demineralization of the periapical bone within a well-defined radiolucent area; and (5) demineralization of the periapical bone with exacerbations and expansion in bone structure.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of separated instrument in a root with a Vertucci's type II configuration (the level of the SI was evaluated using CBCT scans)
Age range 35-55 years
Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root
Exclusion Criteria:
• Patients who refused to undergo radiographic follow-up.
Pregnant females.
Patients suffered from a systemic disease.
Teeth with lesions connected to adjacent teeth.
Teeth with root fractures or perforations.
Teeth with lesion communicating with the alveolar crest.
patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
teeth with damaged or resorbed peri- apex
teeth that were treated with a fiber post and teeth with canal curvature more than 25 degrees
Facility Information:
Facility Name
Faculty of Dentistry, Ainshams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8143573
Citation
Hulsmann M. Methods for removing metal obstructions from the root canal. Endod Dent Traumatol. 1993 Dec;9(6):223-37. doi: 10.1111/j.1600-9657.1993.tb00278.x.
Results Reference
result
PubMed Identifier
14651285
Citation
Ward JR, Parashos P, Messer HH. Evaluation of an ultrasonic technique to remove fractured rotary nickel-titanium endodontic instruments from root canals: an experimental study. J Endod. 2003 Nov;29(11):756-63. doi: 10.1097/00004770-200311000-00017.
Results Reference
result
Learn more about this trial
Success Rates for Management of Separated Instruments
We'll reach out to this number within 24 hrs