Early Loading of Palatal Implants (ortho-type II) a prospective multicenter randomised controlled clinical trial

ISRCTN ISRCTN97142521
DOI https://doi.org/10.1186/ISRCTN97142521
Secondary identifying numbers N/A
Submission date
20/02/2007
Registration date
20/03/2007
Last edited
19/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Britta A. Jung
Scientific

Department of Orthodontics
University Hospital of Mainz
Augustusplatz 2
Mainz
55131
Germany

Phone +49 6131 172692
Email brjung@uni-mainz.de

Study information

Study designProspective multi-center randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleEarly Loading of Palatal Implants (ortho-type II) a prospective multicenter randomised controlled clinical trial
Study acronymELPI
Study objectivesThe 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(s)The Ethics Committee of the State Medical Council of Rhineland-Palatinate, approved on 16 Oct 2006. Ref: 837.210.06 (5308)
Health condition(s) or problem(s) studiedOrthodontic treatment
InterventionImplant 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 typeOther
Primary outcome measureImplants' 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 measuresSecondary 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 study start date01/12/2006
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants124
Key inclusion criteria1. 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
Key exclusion criteriaSystematic 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
Date of first enrolment01/12/2006
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Orthodontics
Mainz
55131
Germany

Sponsor information

Johannes Gutenberg University of Mainz (Germany)
University/education

Langenbeckstr. 1
Mainz
55131
Germany

Website http://www-klinik.uni-mainz.de/
ROR logo "ROR" https://ror.org/023b0x485

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/09/2007 05/01/2021 Yes No
Interim results article 01/08/2011 19/07/2021 Yes No

Editorial Notes

19/07/2021: Publication reference added.
05/01/2021: Publication reference added.