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 measure
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. Patients 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 (if study stopped)
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
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
Basic results (scientific)
Publication list