Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

December 3, 2008 updated by: University of Aarhus

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Faculty of Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Periapical bone healing Pai score
Time Frame: one-year
one-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Periapical bone healing bone density
Time Frame: one-year
one-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Ann Wenzel, professor, faculty of health science, royal dental collegue, department of Oral Radiology, Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2008

Last Update Submitted That Met QC Criteria

December 3, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • journal n. 20050041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alveolar Bone Loss

Clinical Trials on Mineral Trioxide Aggregate (MTA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe