Stomatognathic DiseasePhase 1/2NCT00228280
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
A Phase 1/2 study testing Mineral Trioxide Aggregate (MTA) in people with Stomatognathic Disease and Mouth Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling. The aim of this study is to assess periapical bone healing after apicectomy without a filling and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate risk factors in non-healing cases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stomatognathic Disease, Mouth Disease, Periapical Disease
- What is being tested?
- Mineral Trioxide Aggregate (MTA)
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Sep 2008
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years Pai Score3, 4, or 5
Who cannot join
- boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm
Trial locations and contacts
1 site in 1 country.
About this study
Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.
The aim of this study is to assess periapical bone healing after apicectomy without a filling and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate risk factors in non-healing cases.
Study hypothesis: There is no difference in treatment outcome between:
Periapical bone healing after apicectomy with retrograde root filling and Periapical bone healing after apicectomy without retrograde root filling
Read the detailed description
Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.
60 patients have been selected from a group of 490 patients, who had a full mouth radiographic status taken in connection with a population study of apical periodontitis in Aarhus Community. The selection criteria for the 60 patients were patients with a persisting apical periodontitis, Periapical Index (PAI) score 3-5, on front teeth and premolars in the upper jaw. The orthograde root filling in the tooth must be at least 2 years old and sufficient regarding density and length.
The 60 patients will be randomised into the two groups of apicectomy with and without filling. A radiograph will be taken just before the operation and 6 and 12 months after the operation. In the assessment of bone healing, we will use two different techniques, subtraction radiography and the Periapical Index (PAI).
We will also evaluate the benefits of using the operation microscope during the operation, and if clinical photos can be useful as documentation of treatment result.
- Being tested
- Mineral Trioxide Aggregate (MTA)
- Keywords
- Apicoectomy, Retrograde, MTA
- Medical subject headings
- Stomatognathic Diseases, Mouth Diseases, Periapical Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide Aggregate (MTA)Procedure or surgery
Also called retrograde root filling material, retrofilling
retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical bone healing Pai score
Measured: one-year
Secondary outcomes (1)
Periapical bone healing bone density
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 posted28 Sep 2005 (estimated)
- Study startJan 2005
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomatognathic DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Ann Wenzel, professor, Study director, faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228280
- Sponsor's protocol ID
- journal n. 20050041
- Status last verified
- Dec 2008
- First submitted
- 23 Sep 2005
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
- ClinicalTrials.gov ID
- NCT00228280
- Acronym / sponsor ID
- journal n. 20050041
- Keywords
- Apicoectomy, Retrograde, MTA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Sep 2008 (estimated)
- First posted
- 28 Sep 2005 (estimated)
- 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.
Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.
The aim of this study is to assess periapical bone healing after apicectomy without a filling and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate risk factors in non-healing cases.
Study hypothesis: There is no difference in treatment outcome between:
Periapical bone healing after apicectomy with retrograde root filling and Periapical bone healing after apicectomy without retrograde root filling
Detailed description
Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.
60 patients have been selected from a group of 490 patients, who had a full mouth radiographic status taken in connection with a population study of apical periodontitis in Aarhus Community. The selection criteria for the 60 patients were patients with a persisting apical periodontitis, Periapical Index (PAI) score 3-5, on front teeth and premolars in the upper jaw. The orthograde root filling in the tooth must be at least 2 years old and sufficient regarding density and length.
The 60 patients will be randomised into the two groups of apicectomy with and without filling. A radiograph will be taken just before the operation and 6 and 12 months after the operation. In the assessment of bone healing, we will use two different techniques, subtraction radiography and the Periapical Index (PAI).
We will also evaluate the benefits of using the operation microscope during the operation, and if clinical photos can be useful as documentation of treatment result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years Pai Score3, 4, or 5
Key exclusion criteria (1 listed)
- boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm
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 |
|---|---|---|
| Mineral Trioxide Aggregate (MTA)Also: retrograde root filling material, retrofillingretrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha | Procedure or surgery | – |
Primary outcome
Periapical bone healing Pai score
Time frame: one-year
1 secondary outcome
Periapical bone healing bone density
Time frame: one-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
- Department of Oral Radiology, Royal Dental Colleague, Aarhus, DenmarkLink provided by the sponsor.
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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.
Ann Wenzel, professor study director
faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mineral Trioxide Aggregate (MTA) in people with Stomatognathic Disease and Mouth Disease, run by University of Aarhus at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2008. 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 Denmark. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Periapical bone healing Pai score (time frame: one-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2008.