Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

• ClinicalTrials.gov Identifier: NCT00228280
• Recruitment Status: Unknown
• First Posted: September 28, 2005
• Last Update Posted: December 4, 2008
• Sponsor: University of Aarhus
• Information provided by: University of Aarhus

Tracking Information

• First Submitted Date: September 23, 2005
• First Posted Date: September 28, 2005
• Last Update Posted Date: December 4, 2008
• Study Start Date: January 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 30, 2007): Periapical bone healing Pai score [ Time Frame: one-year ]
• Original Primary Outcome Measures (submitted: September 23, 2005): Periapical bonehealing Pai score
• Current Secondary Outcome Measures (submitted: November 30, 2007): Periapical bone healing bone density [ Time Frame: one-year ]
• Original Secondary Outcome Measures (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: Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Stomatognathic Disease
• Mouth Disease
• Periapical Disease
• Alveolar Bone Loss

Intervention

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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 23, 2005): 54
• Original Enrollment: Same as current
• Estimated Study Completion Date: September 2008
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00228280
• Other Study ID Numbers: journal n. 20050041
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Professor, Ann Wenzel, department of Oral Radiology, School of Dentistry, University of Aarhus, Denmark
• Study Sponsor: University of Aarhus
• Collaborators: Not Provided

Investigators

• 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