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Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

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ClinicalTrials.gov Identifier: NCT00228280
Recruitment Status : Unknown
Verified December 2008 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : December 4, 2008
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 23, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date December 4, 2008
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Periapical bone healing Pai score [ Time Frame: one-year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2005)
Periapical bonehealing Pai score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Periapical bone healing bone density [ Time Frame: one-year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2005)
Periapical boneheling bone density
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
Official Title  ICMJE Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stomatognathic Disease
  • Mouth Disease
  • Periapical Disease
  • Alveolar Bone Loss
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 23, 2005)
54
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228280
Other Study ID Numbers  ICMJE journal n. 20050041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor, Ann Wenzel, department of Oral Radiology, School of Dentistry, University of Aarhus, Denmark
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ann Wenzel, professor faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
PRS Account University of Aarhus
Verification Date December 2008

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