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

Not Applicable

Completed

• Conditions: Bone Loss, Alveolar
• Interventions: Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants; Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition

• Registration Number: NCT04144322
• Lead Sponsor: University of Michigan

Brief Summary

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)

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-10-14
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in mesial-distal (M-D) bone loss	Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months	Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.

Secondary Outcome Measures

Name	Time	Method
Number of sites with bleeding on probing	5 month post-op, 12 month post-op, and 24 month post-op visits	The number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
Probing pocket depth	5 month post-op, 12 month post-op, and 24 month post-op visits	The probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
Survival rate	5 month post-op, 12 month post-op, and 24 month post-op visits	The survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States