This trial is active, not recruiting.

Conditions stomatognathic disease, mouth disease, periapical disease, alveolar bone loss
Treatment mineral trioxide aggregate (mta)
Phase phase 1/phase 2
Sponsor University of Aarhus
Start date January 2005
End date September 2008
Trial size 54 participants
Trial identifier NCT00228280, journal n. 20050041


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Periapical bone healing Pai score
time frame: one-year

Secondary Outcomes

Periapical bone healing bone density
time frame: one-year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by University of Aarhus.