Condition category
Oral Health
Date applied
20/02/2007
Date assigned
20/03/2007
Last edited
03/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Britta A. Jung

ORCID ID

Contact details

Department of Orthodontics
University Hospital of Mainz
Augustusplatz 2
Mainz
55131
Germany
+49 6131 172692
brjung@uni-mainz.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ELPI

Study hypothesis

The objective of the clinical study proposal will be to investigate the performance of early functional palatal implant loading in order to find out whether early orthodontic loading without the typical healing period is a clinically safe procedure - and might, thus, be justified to accelerate active orthodontic treatment. Concerning this matter the following null hypothesis will be addressed: There will be no difference between standard therapy (implant loading after a post-surgical healing period of 12 weeks) and early loading group concerning implant failure rate.

Ethics approval

The Ethics Committee of the State Medical Council of Rhineland-Palatinate, approved on 16 Oct 2006. Ref: 837.210.06 (5308)

Study design

Prospective multi-center randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Orthodontic treatment

Intervention

Implant loading after a post-surgical healing period of 12 weeks vs early implant loading within 1 week post implantation.

Surgical enquiry:
Prof M. Kunkel
Department of Oral and Maxillofacial Surgery
University Hospital of Mainz
55131 Mainz
Germany
Email: kunkel@mkg.klinik.uni-mainz.de
Tel: +49 6131 175458

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Implants' stability after a loading time of 6 and 12 months of function after implant placement. The criteria of implant success are:
1. Implant survival
2. No abnormal mobility

Secondary outcome measures

Secondary clinical endpoints will include:
1. Achievement of partial orthodontic treatment success 12 months after implant insertion
2. Quantity of direct implant-bone interface of the removed bone specimens
3. Patient’s acceptance rate of palatal implants
4. Anchorage loss of the anchor tooth unit and overall success after completion of active treatment.

As a tertiary endpoint, a histological and microtomography evaluation of all retrieved implants (about 2-3 years after placement) will be performed to obtain data on the performance of the sandblasted and acid-etched surface (SLA) surface in human bone.
In addition, a comparison between histomorphometric and microtomographic analyses will be performed on each specimen to evaluate the possibility of microtomography and to calibrate the technology for implant osseointegration assessment. Moreover, the measurement reliability of the resonance frequency measuring device (OsstellTM mentor) in the assessment of implant stability will be evaluated by comparison between ISQ (implant stability quotient) values and the quantity of direct implant-bone interface of all retrieved implants.

Overall trial start date

01/12/2006

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Need and desire for an implant-supported orthodontic treatment, needed for maximum anchorage
2. Patients must have adequate bone quantity based on lateral radiographs
3. Patients must have adequate oral hygiene and “normal” wound healing capacity
4. Patients must be willing to be present for clinical examinations and must have signed the informed consent form
5. Female patients may only participate if they have undergone a urine pregnancy test for pregnancy exclusion

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

124

Participant exclusion criteria

Systematic exclusion criteria:
1. Patients requiring chronic prophylactic usage of antibiotics
2. Patients, receiving any therapy that suppresses their immune system, such as a prolonged steroid usage, radiation or chemotherapy
3. Patients with medical history of bleeding disorders, of renal failures, of leucocyte dysfunctions or deficiencies
4. Patients with metabolic bone or uncontrolled endocrine disorders
5. Patients with craniofacial anomalies and/or physical handicaps that would interfere with the ability to perform adequate oral hygiene
6. Patients who participate in other studies requiring continuing investigational medication 7. Patients with alcohol and/or drug abuse
8. Female patients with a positive urine pregnancy test result

Local exclusion criteria:
1. Patients with inadequate oral hygiene
2. Occurrence of local inflammation, including untreated periodontitis
3. Mucosal diseases
4. History of local irradiation therapy
5. Presence of osseous lesions
6. Persistent intraoral infection
7. Lack of primary stability of the implant at surgery

Recruitment start date

01/12/2006

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Orthodontics
Mainz
55131
Germany

Sponsor information

Organisation

Johannes Gutenberg University of Mainz (Germany)

Sponsor details

Langenbeckstr. 1
Mainz
55131
Germany

Sponsor type

University/education

Website

http://www-klinik.uni-mainz.de/

Funders

Funder type

Research organisation

Funder name

The ITI Foundation for the Promotion of Oral Implantology (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes