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
Scientific
Department of Orthodontics
University Hospital of Mainz
Augustusplatz 2
Mainz
55131
Germany
| Phone | +49 6131 172692 |
|---|---|
| brjung@uni-mainz.de |
Study information
| Study design | Prospective multi-center randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/12/2006 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
55131
Germany
Sponsor information
Johannes Gutenberg University of Mainz (Germany)
University/education
University/education
Langenbeckstr. 1
Mainz
55131
Germany
| Website | http://www-klinik.uni-mainz.de/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
