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

ISRCTN	ISRCTN97142521
DOI	https://doi.org/10.1186/ISRCTN97142521
Protocol serial number	N/A
Sponsor	Johannes Gutenberg University of Mainz (Germany)
Funder	The ITI Foundation for the Promotion of Oral Implantology (Switzerland)

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

Primary study design	Interventional
Study design	Prospective multi-center randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Early Loading of Palatal Implants (ortho-type II) a prospective multicenter randomised controlled clinical trial
Study acronym	ELPI
Study objectives	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(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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	124
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Germany

Study participating centre

Department of Orthodontics

Mainz
55131
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.