NCT03108183

Brief Summary

The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 2, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

March 17, 2017

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Appearance of periapical lesions on tooth after root resection

    Appearance assessed by X-ray and classified according to Molven et al. (1987)

    1 day

  • Size of periapical lesions on tooth after root resection

    Size assessed by X-ray and classified according to Molven et al. (1987)

    1 day

Secondary Outcomes (3)

  • Vertical and horizontal bone loss on the tooth after root resection

    1 day

  • Occurrence of tooth fractures

    1 day

  • Occurrence of tooth loss

    1 day

Interventions

x-raysDIAGNOSTIC_TEST

To get further and actual information about periapical lesions, different x-rays will be done (panoramic radiographic, small picture ray, cone beam computed tomography). Furthermore a periodontal status will be performed.

Eligibility Criteria

Age27 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

You may qualify if:

  • All 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

You may not qualify if:

  • Pregnancy
  • Patients who do not want to participate in clinical and radiological follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Graz, 8036, Austria

Location

Related Publications (1)

  • Molven O, Halse A, Grung B. Observer strategy and the radiographic classification of healing after endodontic surgery. Int J Oral Maxillofac Surg. 1987 Aug;16(4):432-9. doi: 10.1016/s0901-5027(87)80080-2.

    PMID: 3117915BACKGROUND

MeSH Terms

Conditions

Periapical Diseases

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Norbert Jakse, MD

    Department of dental medicine and oral health, Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 11, 2017

Study Start

March 2, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations