Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
Primary Purpose
Stomatognathic Disease, Mouth Disease, Periapical Disease
Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Mineral Trioxide Aggregate (MTA)
Sponsored by
About this trial
This is an interventional treatment trial for Stomatognathic Disease focused on measuring Apicoectomy, Retrograde, MTA
Eligibility Criteria
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
Sites / Locations
- Faculty of Health Science
Outcomes
Primary Outcome Measures
Periapical bone healing Pai score
Secondary Outcome Measures
Periapical bone healing bone density
Full Information
NCT ID
NCT00228280
First Posted
September 23, 2005
Last Updated
December 3, 2008
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00228280
Brief Title
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
Official Title
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatognathic Disease, Mouth Disease, Periapical Disease, Alveolar Bone Loss
Keywords
Apicoectomy, Retrograde, MTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Mineral Trioxide Aggregate (MTA)
Other Intervention Name(s)
retrograde root filling material, retrofilling
Intervention Description
retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha
Primary Outcome Measure Information:
Title
Periapical bone healing Pai score
Time Frame
one-year
Secondary Outcome Measure Information:
Title
Periapical bone healing bone density
Time Frame
one-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Wenzel, professor
Organizational Affiliation
faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Health Science
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.odont.au.dk/rad/default.html
Description
Department of Oral Radiology, Royal Dental Colleague, Aarhus, Denmark
Learn more about this trial
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
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