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

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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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Short Implant
Other group
Description:
17 patients will receive a 5 mm short implant.
Treatment:
Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Long Implant
Other group
Description:
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Treatment:
Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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