NCT00228280

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 4, 2008

Status Verified

December 1, 2008

First QC Date

September 23, 2005

Last Update Submit

December 3, 2008

Conditions

Stomatognathic DiseaseMouth DiseasePeriapical DiseaseAlveolar Bone Loss

Keywords

ApicoectomyRetrogradeMTA

Outcome Measures

Primary Outcomes (1)

  • Periapical bone healing Pai score

    one-year

Secondary Outcomes (1)

  • Periapical bone healing bone density

    one-year

Interventions

Mineral Trioxide Aggregate (MTA)PROCEDURE

retrograde rootfilling with MTA or smoothening of the orthograde root-filling, gutta-percha

Also known as: retrograde root filling material, retrofilling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years Pai Score3, 4, or 5

You may not qualify if:

  • boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science

Aarhus, Aarhus C, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

Stomatognathic DiseasesMouth DiseasesPeriapical DiseasesAlveolar Bone Loss

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Jaw DiseasesPeriodontal DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Officials

  • Ann Wenzel, professor

    faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 28, 2005

Study Start

January 1, 2005

Study Completion

September 1, 2008

Last Updated

December 4, 2008

Record last verified: 2008-12

Locations

DK(1)