4 mm Implants in Fixed Cross-Arch Prostheses (NCT02877433) | Clinical Trial Compass
CompletedNot Applicable
4 mm Implants in Fixed Cross-Arch Prostheses
Switzerland, United Kingdom53 participantsStarted 2016-08
Plain-language summary
This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants of conventional length placed in the interforaminal region, or with a combination of four short implants as distal support and two interforaminal implants of conventional length.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and females with at least 18 years of age (including 18 years)
* Subject must have voluntarily signed the informed consent, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Fully edentulous (latest extraction in the mandible should be performed at least 12 weeks before implant placement) that can be restored with a complete denture
* Atrophic jaw bone in the posterior area, sufficient bone height and width to permit insertion of four short implants, 4 mm in regions of the first molar and second premolar on both sides and two standard length implants in the canine region
Exclusion Criteria:
* Patients with inadequate bone volume and/or quality
* Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* History of local irradiation therapy in the head / neck area
* Patients who smoke \>10 cigarettes per day or tobacco equivalents, chew tobacco or have ≥ 20 pack years
* Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
* Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-c…