Teeth, Endodontically-TreatedNCT05342246
Success Rates for Management of Separated Instruments
A study testing Endodontic retreatment in people with Teeth, Endodontically-Treated, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach Read more about this study
- Who is it for?
- Ages 33 to 55 years
- Conditions the study is for
- Teeth, Endodontically-Treated
- What is being tested?
- Endodontic retreatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 33 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- • 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success Rates for Management of Separated Instruments in Canals With Type II Vertucci's Classification: Prospective Clinical Study
The study compares the prognosis of cases of Separated Instruments in Canals With Type II Vertucci's Classification treated with conservative approach
Read the 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)
- Conditions
- Teeth, Endodontically-Treated
- Being tested
- Endodontic retreatment
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic retreatmentProcedure or surgery
retreatment of the patent root canal only without attempt to retrieve the separated instrument
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Experimental | The patent canal is retreated, no attempt to deal with the separated instrument Receives: Procedure: Endodontic retreatment |
| traditional | Active comparator | All canals are retreated with attempts to retrieve the broken file Receives: Procedure: Endodontic retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Teeth, Endodontically-TreatedStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mokhtar Nagy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342246
- Sponsor's protocol ID
- FDASU-Rec IR012249
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8143573Ward 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.
PubMed 14651285
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rates for Management of Separated Instruments in Canals With Type II Vertucci's Classification: Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05342246
- Acronym / sponsor ID
- FDASU-Rec IR012249
- Conditions
- Teeth, Endodontically-Treated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Apr 2022 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | Experimental | Procedure: Endodontic retreatmentThe patent canal is retreated, no attempt to deal with the separated instrument |
| traditional | Active comparator | Procedure: Endodontic retreatmentAll canals are retreated with attempts to retrieve the broken file |
Who may qualify
- Ages
- 33 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- • Patients who refused to undergo radiographic follow-up.
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 |
|---|---|---|
| Endodontic retreatmentretreatment of the patent root canal only without attempt to retrieve the separated instrument | Procedure or surgery | conservative treatment, traditional |
Primary outcome
monitoring of periapical index
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Results publication: PubMed 8143573Hulsmann 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 publication: PubMed 14651285Ward 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic retreatment in people with Teeth, Endodontically-Treated, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monitoring of periapical index (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342246, which also lists 2 linked publications.
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 Apr 2022.