Periapical DiseasesNCT03108183
Apicoectomy Longterm Results
An observational study of Periapical Diseases, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown. Read more about this study
- Who is it for?
- Ages 27 to 79 years
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- x-rays
- How many people
- 73 participants
- Where
- 1 siteAustria
- Study dates
- 2 Mar 2017to 31 Aug 2017
- 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 27 to 79 years
- All sexes
- Adult, Older adult
Study population: 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
Who may be able to join
- All 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
Who cannot join
- Pregnancy
- Patients who do not want to participate in clinical and radiological follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Longterm Treatment Results After Micro-surgical Root Resection of Teeth With Post and Core and Crown
The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.
Read the detailed description
All 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
The patients will have a clinical and radiologic examination. The investigators will examine if new periapical lesions, bone loss, fracture of teeth or loss of teeth exist.
- Conditions
- Periapical Diseases
- Being tested
- x-rays
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-raysDiagnostic test
To get further and actual information about periapical lesions, different x-rays will be done (panoramic radiographic, small picture ray, cone beam computed tomography). Furthermore a periodontal status will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of periapical lesions on tooth after root resection
Appearance assessed by X-ray and classified according to Molven et al. (1987)
Measured: 1 day
Size of periapical lesions on tooth after root resection
Size assessed by X-ray and classified according to Molven et al. (1987)
Measured: 1 day
Secondary outcomes (3)
Vertical and horizontal bone loss on the tooth after root resection
Bone loss in mm assessed by X-ray and probing
Measured: 1 day
Occurrence of tooth fractures
Number of tooth fractures assessed by X-ray
Measured: 1 day
Occurrence of tooth loss
Number of tooth losses assessed by clinical and radiological evaluation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start2 Mar 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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 Periapical DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Jakse, MD, Principal investigator, Department of dental medicine and oral health, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108183
- Sponsor's protocol ID
- Angel
- Other IDs
- 29-214 ex 16/17
- Status last verified
- Feb 2018
- First submitted
- 17 Mar 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molven O, Halse A, Grung B. Observer strategy and the radiographic classification of healing after endodontic surgery. Int J Oral Maxillofac Surg. 1987 Aug;16(4):432-9. doi: 10.1016/s0901-5027(87)80080-2.
PubMed 3117915
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Longterm Treatment Results After Micro-surgical Root Resection of Teeth With Post and Core and Crown
- ClinicalTrials.gov ID
- NCT03108183
- Acronym / sponsor ID
- Angel
- Conditions
- Periapical Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 Apr 2017 (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 purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.
Detailed description
All 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
The patients will have a clinical and radiologic examination. The investigators will examine if new periapical lesions, bone loss, fracture of teeth or loss of teeth exist.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 27 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
Key inclusion criteria (1 listed)
- All 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.
Key exclusion criteria (2 listed)
- Pregnancy
- Patients who do not want to participate in clinical and radiological 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 |
|---|---|---|
| x-raysTo get further and actual information about periapical lesions, different x-rays will be done (panoramic radiographic, small picture ray, cone beam computed tomography). Furthermore a periodontal status will be performed. | Diagnostic test | – |
Primary outcome
Appearance of periapical lesions on tooth after root resection
Time frame: 1 day
Appearance assessed by X-ray and classified according to Molven et al. (1987)
Size of periapical lesions on tooth after root resection
Time frame: 1 day
Size assessed by X-ray and classified according to Molven et al. (1987)
3 secondary outcomes
Vertical and horizontal bone loss on the tooth after root resection
Time frame: 1 day
Occurrence of tooth fractures
Time frame: 1 day
Occurrence of tooth loss
Time frame: 1 day
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 23 Feb 2018.
- Background: PubMed 3117915Molven O, Halse A, Grung B. Observer strategy and the radiographic classification of healing after endodontic surgery. Int J Oral Maxillofac Surg. 1987 Aug;16(4):432-9. doi: 10.1016/s0901-5027(87)80080-2.
- Individual participant dataSharing planned: No
Related trials for Periapical Diseases
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
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.
Norbert Jakse, MD principal investigator
Department of dental medicine and oral health, Medical University of Graz
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 Periapical Diseases, run by Medical University of Graz at 1 site in Austria.
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 1 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 23 Feb 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 Austria. 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?
Appearance of periapical lesions on tooth after root resection (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03108183, 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 23 Feb 2018.