Orthodontic treatment Oral Health Orthodontic treatment
Conditions
Interventions
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
Sponsors
Johannes Gutenberg University of Mainz (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed