- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228280
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Aarhus C
-
Aarhus, Aarhus C, Denmark, 8000
- Faculty of Health Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years Pai Score3, 4, or 5
Exclusion Criteria:
boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Periapical bone healing Pai score
Time Frame: one-year
|
one-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Periapical bone healing bone density
Time Frame: one-year
|
one-year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ann Wenzel, professor, faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- journal n. 20050041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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