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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Periapical bone healing Pai score [ Time Frame: one-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Periapical bone healing bone density [ Time Frame: one-year ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: January 2005
Estimated Study Completion Date: September 2008
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228280

Locations
Denmark
Faculty of Health Science
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Ann Wenzel, professor faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus
  More Information

No publications provided

Responsible Party: Professor, Ann Wenzel, department of Oral Radiology, School of Dentistry, University of Aarhus, Denmark
ClinicalTrials.gov Identifier: NCT00228280     History of Changes
Other Study ID Numbers: journal n. 20050041
Study First Received: September 23, 2005
Last Updated: December 3, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Apicoectomy
Retrograde
MTA

Additional relevant MeSH terms:
Alveolar Bone Loss
Mouth Diseases
Periapical Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Jaw Diseases

ClinicalTrials.gov processed this record on April 22, 2014