Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00228280
First received: September 23, 2005
Last updated: December 3, 2008
Last verified: December 2008

September 23, 2005
December 3, 2008
January 2005
Not Provided
Periapical bone healing Pai score [ Time Frame: one-year ] [ Designated as safety issue: Yes ]
Periapical bonehealing Pai score
Complete list of historical versions of study NCT00228280 on ClinicalTrials.gov Archive Site
Periapical bone healing bone density [ Time Frame: one-year ] [ Designated as safety issue: Yes ]
Periapical boneheling bone density
Not Provided
Not Provided
 
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stomatognathic Disease
  • Mouth Disease
  • Periapical Disease
  • Alveolar Bone Loss
Procedure: Mineral Trioxide Aggregate (MTA)
retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha
Other Names:
  • retrograde root filling material
  • retrofilling
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
September 2008
Not Provided

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00228280
journal n. 20050041
No
Professor, Ann Wenzel, department of Oral Radiology, School of Dentistry, University of Aarhus, Denmark
University of Aarhus
Not Provided
Study Director: Ann Wenzel, professor faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
University of Aarhus
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP