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NCT00228280 Clinical Trial

Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Alveolar Bone Loss Clinical Trial

Official title:
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00228280
Other study ID # journal n. 20050041
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received September 23, 2005
Last updated December 3, 2008
Start date January 2005
Est. completion date September 2008

Study information
Verified date December 2008
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical 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.

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 54
Est. completion date September 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Mineral Trioxide Aggregate (MTA)
retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha

Locations
Country Name City State
Denmark Faculty of Health Science Aarhus Aarhus C

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Periapical bone healing Pai score one-year Yes
Secondary Periapical bone healing bone density one-year Yes
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