Bone ResorptionmicrosurgeryNCT03733938
Microsurgery Using a Bioceramic Root End Filling Material
An observational study of Bone Resorption and Symptoms, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy. Endodontic microsurgery is one way to manage such failure. The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Bone Resorption, Symptoms
- What is being tested?
- endodontic microsurgery
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 6 Jan 2017to 5 Aug 2018
- Phase
- Observational
- 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: All eligible patients attending the postgraduate clinics over a 7 months period and meet the inclusion criteria will be included in the study
Who may be able to join
- medically fit patient
- Tooth has adequate coronal seala nd judged restorable
- previously root filled tooth with persistent periapical lesion
- previously retreated tooth with persistent symptoms 5.previously tretaed tooth with inaccessable canal for retreatment 6. combined nonsurgical and surgical approach for teeth with large periapical lesions
Who cannot join
- medically compromised patients
- nonrestorable teeth cracked roots
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Periradicular Microsurgery Using a Bioceramic Root End Filling Material
Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy. Endodontic microsurgery is one way to manage such failure. The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery. The aim of this study was to investigate the clinical and radiographic outcome of a fast set bioceramic root end filling material in human teeth.
Read the detailed description
Patients who were referred to the endodontic postgraduate clinics in the period between January 2017 till August 2017 were assessed for inclusion in the study according to preset criteria. Endodontic microsurgery was performed following modern techniques including magnification, root resection with minimal angle, ultrasonic root end preparation and placement of a fast set bioceramic putty as retrograde filling material. The case was subsequently evaluated clinically and radiographically at 3, 6 and 12 months. And will be followed subsequently at 2 years and 4 years post treatment.
- Conditions
- Bone Resorption, Symptoms
- Being tested
- endodontic microsurgery
- Keywords
- rarifaction, root end filling, bioceramic, outcome
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endodontic microsurgeryOther
teeth with failed root canal treatment will be treated by endodontic microsurgery
| Study group | Role | What they receive |
|---|---|---|
| teeth with failed root canal treatement | endodontic microsurgery will be performed for teeth with failed root canal treatment Receives: Other: endodontic microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of signs of failure in the root treated tooth
symptoms should disappear and signs of bone healing should be evident on the radio graph
Measured: 6 months -1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start6 Jan 2017
- Primary completion7 Aug 2017
- Study completion5 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nessrin Taha, DCD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733938
- Sponsor's protocol ID
- 316/2016
- Acronym
- microsurgery
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: participant data can be shared after the first publication from the study.
Publications
Taha NA, Aboyounes FB, Tamimi ZZ. Root-end microsurgery using a premixed tricalcium silicate putty as root-end filling material: a prospective study. Clin Oral Investig. 2021 Jan;25(1):311-317. doi: 10.1007/s00784-020-03365-7. Epub 2020 Jun 2.
PubMed 32483680
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Periradicular Microsurgery Using a Bioceramic Root End Filling Material
- ClinicalTrials.gov ID
- NCT03733938
- Acronym / sponsor ID
- microsurgery / 316/2016
- Conditions
- Bone Resorption, Symptoms
- Keywords
- rarifaction, root end filling, bioceramic, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 7 Nov 2018 (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.
Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy. Endodontic microsurgery is one way to manage such failure. The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery. The aim of this study was to investigate the clinical and radiographic outcome of a fast set bioceramic root end filling material in human teeth.
Detailed description
Patients who were referred to the endodontic postgraduate clinics in the period between January 2017 till August 2017 were assessed for inclusion in the study according to preset criteria. Endodontic microsurgery was performed following modern techniques including magnification, root resection with minimal angle, ultrasonic root end preparation and placement of a fast set bioceramic putty as retrograde filling material. The case was subsequently evaluated clinically and radiographically at 3, 6 and 12 months. And will be followed subsequently at 2 years and 4 years post treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teeth with failed root canal treatement | – | Other: endodontic microsurgeryendodontic microsurgery will be performed for teeth with failed root canal treatment |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients attending the postgraduate clinics over a 7 months period and meet the inclusion criteria will be included in the study
Key inclusion criteria (4 listed)
- medically fit patient
- Tooth has adequate coronal seala nd judged restorable
- previously root filled tooth with persistent periapical lesion
- previously retreated tooth with persistent symptoms 5.previously tretaed tooth with inaccessable canal for retreatment 6. combined nonsurgical and surgical approach for teeth with large periapical lesions
Key exclusion criteria (2 listed)
- medically compromised patients
- nonrestorable teeth cracked roots
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 microsurgeryteeth with failed root canal treatment will be treated by endodontic microsurgery | Other | teeth with failed root canal treatement |
Primary outcome
Resolution of signs of failure in the root treated tooth
Time frame: 6 months -1 year
symptoms should disappear and signs of bone healing should be evident on the radio graph
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 7 Nov 2018.
- Derived from this study: PubMed 32483680Taha NA, Aboyounes FB, Tamimi ZZ. Root-end microsurgery using a premixed tricalcium silicate putty as root-end filling material: a prospective study. Clin Oral Investig. 2021 Jan;25(1):311-317. doi: 10.1007/s00784-020-03365-7. Epub 2020 Jun 2.
- Individual participant dataSharing planned: Undecided. participant data can be shared after the first publication from the study.
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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.
Nessrin Taha, DCD study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Resorption and Symptoms, run by Jordan University of Science and Technology at 1 site in Jordan.
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 4 inclusion and 2 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 7 Nov 2018. 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 Jordan. 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?
Resolution of signs of failure in the root treated tooth (time frame: 6 months -1 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 NCT03733938, which also lists 1 linked publication.
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 7 Nov 2018.