Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

University of Michigan

Status

Active, not recruiting

Conditions

Bone Loss, Alveolar

Treatments

Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition

Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants

Study type

Interventional

Funder types

Other

Identifiers

NCT04144322

HUM00151047

Details and patient eligibility

About

The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.

Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)

Full description

34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.

Enrollment

34 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 20-70 years at enrollment
Systemically healthy patients
Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
In need of one premolar or 1st molar dental implant in the maxillary area
Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation
Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.

Exclusion criteria

Unlikely to be able to comply with study procedures
Uncontrolled pathologic processes in the oral cavity
History of head and neck chemotherapy within 5 years prior to surgery
Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
Uncontrolled diabetes mellitus HbA1c >8
Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
Smokes more than 10 cigarettes/day
Bruxer
Present alcohol and/or drug abuser
Pregnant, unsure pregnancy status, or lactating females (self-reported)