Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT00228280

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stomatognathic Disease Mouth Disease Periapical Disease Alveolar Bone Loss	Procedure: Mineral Trioxide Aggregate (MTA)	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Study Start Date :

Jan 1, 2005

Anticipated Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

Periapical bone healing Pai score [one-year]

Secondary Outcome Measures

Periapical bone healing bone density [one-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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