Clinical trial NCT04327284: Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
Official title: Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets
Keywords: Immediate
Molar
Extraction
Sockets
Bone Graft
Dental Implant
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Straumann USA
First posted: 2020-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a single site, randomized, controlled, prospective, and parallel arms study.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.

Detailed description: Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.

15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:

Test Group (n=15):

The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).

Control Group (n=15):

The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm).

Subject Recruitment Methods and Privacy:

Subjects who seek implant treatment in University of Kentucky, College of Dentistry clinics. Implant clinics is referral base clinic. Once a subject is referred to extract a nonrestorable molar tooth and be replaced with an implant, potential subjects will be informed with the study. If subjects decide to be part of the study, informed consent will be signed prior to screening visit.

Informed Consent Process:

The research study will be conducted at the facilities of University of Kentucky, College of Dentistry after approval by the Institutional Review Board. All members of the research team received training in human subject protection. After each patient has been given verbal and written information describing the nature of the study, informed consent will be obtained before he or she can enter the study. A copy of the consent form will be given to the patient and another retained by the investigator. Patients will not be screened until an informed consent has been obtained.

Eligibility criteria: Inclusion Criteria:

* 22 years of age or older
* good general health.
* at least one nonrestorable more indicated for extraction and immediate or delayed implant placement

Exclusion Criteria:

* undergo oral surgery procedures
* smokers
* women who are (or become) pregnant (or are breastfeeding)
* subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)

Primary outcomes:
measure: Clinical Examination: Implant Success and Failure Criteria
timeFrame: 12 months
measure: Radiographic Examination
timeFrame: 12 months
measure: Osstell Value Assessment
timeFrame: 12 months
measure: 3D Printed Models Assessment
timeFrame: 12 months
measure: Photographic Documentation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ahmad KutKut, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: