Teeth, Endodontically-TreatedNCT04737863
Minimally Invasive Management During Endodontic Retreatment
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 treated with "selective root retreatment" to the cases treated with traditional retreatment approach Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- 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
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 30 Apr 2021
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- endodontically treated teeth
- multirooted teeth
- radiographic evidence of periradicular infection related to one root
Who cannot join
- medically compromised patients
- fused roots
- root resorption
- root fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Management of Separated Instruments in Vertucci Type ii Canals: A Radomized Clinical Trial
The study compares the prognosis of cases treated with "selective root retreatment" to the cases treated with traditional retreatment approach
Read the detailed description
Post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .Conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. Nowadays, All operations in the medical field are aimed basically at the conservation of the human body. The alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole.
The literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.
- 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
Root canal retreatment in cases with secondary root canal infection
| Study group | Role | What they receive |
|---|---|---|
| selective root canal retreatment | Experimental | retreatment process is performed to the affected root only Receives: Procedure: Endodontic retreatment |
| traditional root canal retreatment | Active comparator | retreatment process is performed to all roots Receives: Procedure: Endodontic retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
volumetric change of periapical lesion size in CBCT
assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jan 2020
- Primary completion12 Mar 2021
- Study completion30 Apr 2021
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.
- 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
- 40 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
- Investigators
- Mohamed M Nagy, PhD, Principal investigator, Associate professor of Endodontics, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737863
- Sponsor's protocol ID
- ASFD-ENDO-2
- Status last verified
- Jul 2021
- First submitted
- 30 Jan 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nudera WJ. Selective Root Retreatment: A Novel Approach. J Endod. 2015 Aug;41(8):1382-8. doi: 10.1016/j.joen.2015.02.035. Epub 2015 Apr 21.
PubMed 25906919Liang YH, Li G, Wesselink PR, Wu MK. Endodontic outcome predictors identified with periapical radiographs and cone-beam computed tomography scans. J Endod. 2011 Mar;37(3):326-31. doi: 10.1016/j.joen.2010.11.032.
PubMed 21329816
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Management of Separated Instruments in Vertucci Type ii Canals: A Radomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04737863
- Acronym / sponsor ID
- ASFD-ENDO-2
- Conditions
- Teeth, Endodontically-Treated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Feb 2021 (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 treated with "selective root retreatment" to the cases treated with traditional retreatment approach
Detailed description
Post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .Conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. Nowadays, All operations in the medical field are aimed basically at the conservation of the human body. The alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole.
The literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selective root canal retreatment | Experimental | Procedure: Endodontic retreatmentretreatment process is performed to the affected root only |
| traditional root canal retreatment | Active comparator | Procedure: Endodontic retreatmentretreatment process is performed to all roots |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- endodontically treated teeth
- multirooted teeth
- radiographic evidence of periradicular infection related to one root
Key exclusion criteria (4 listed)
- medically compromised patients
- fused roots
- root resorption
- root fracture
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 retreatmentRoot canal retreatment in cases with secondary root canal infection | Procedure or surgery | selective root canal retreatment, traditional root canal retreatment |
Primary outcome
volumetric change of periapical lesion size in CBCT
Time frame: one year
assessment of healing of periradicular infection in terms of change of the size of periapical lesion in CBCT analysis
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 27 Jul 2021.
- Results publication: PubMed 25906919Nudera WJ. Selective Root Retreatment: A Novel Approach. J Endod. 2015 Aug;41(8):1382-8. doi: 10.1016/j.joen.2015.02.035. Epub 2015 Apr 21.
- Results publication: PubMed 21329816Liang YH, Li G, Wesselink PR, Wu MK. Endodontic outcome predictors identified with periapical radiographs and cone-beam computed tomography scans. J Endod. 2011 Mar;37(3):326-31. doi: 10.1016/j.joen.2010.11.032.
- 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.
Mohamed M Nagy, PhD principal investigator
Associate professor of Endodontics, Ain Shams University
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 4 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 27 Jul 2021. 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?
volumetric change of periapical lesion size in CBCT (time frame: one year). 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 NCT04737863, 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 27 Jul 2021.