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

Not Applicable

• Conditions: Orthodontic treatment; Oral Health

• Registration Number: ISRCTN97142521
• Lead Sponsor: Johannes Gutenberg University of Mainz (Germany)

Brief Summary

2007 Protocol article in https://pubmed.ncbi.nlm.nih.gov/17883841/ protocol (added 05/01/2021) 2011 Interim results article in https://pubmed.ncbi.nlm.nih.gov/20383544/ (added 19/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-20
• Study Completion: 2011-12-31
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 124

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Implants' stability after a loading time of 6 and 12 months of function after implant placement. The criteria of implant success are:<br> 1. Implant survival<br> 2. No abnormal mobility<br>