Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets

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.

Study Overview

• Status: Withdrawn
• Conditions: Immediate Placement of Straumann BLX Implants in Molar Extraction Sockets
• Intervention / Treatment: Device: Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm); Device: Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm)

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).	Device: Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm); At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.
Active Comparator: Control group; 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).	Device: Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm); At the screening visit, potential subjects will be informed about the protocol and all questions related to the study will be answered. Medical and dental histories will be reviewed and physical evaluations will be performed in order to rule out local or systemic factors that would compromise the outcome of the study. A detailed extra and intra oral examination will be performed. Appropriate radiographic imaging studies will be obtained prior to the surgical visit (per the protocol of the University of Kentucky, College of Dentistry) including CBCT and intraoral scans for treatment planning implant through Straumann Guided Surgery workflow. The duration of the present study is 1 year including the baseline or surgical visit, 2-weeks postoperative visit, 12-weeks baseline for control group and postoperative evaluations at 3, and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Examination: Implant Success and Failure Criteria	Implant success is defined by clinical and radiographic parameters. The success criteria for the implants will be (1) no radiolucency around the implant, (2) no mobility, and (3) no suppuration, pain, or ongoing pathologic process. Implants that do not meet the above criteria fall under the implant failure category. Success rate percentage will be based on clinical and radiographic assessment per implant site.	12 months
Radiographic Examination	Regional Cone Beam CT scan imaging for implant sites will be made for research purposes at baseline after implant placement, and 12 months follow up visits. These images are the only way to provide 3 dimensional view of bone around implants (Mesial-Distal, Buccal-Lingual). Marginal bone level changes will be recorded on the mid-mesial, mid-distal, mid-labial, and mid-lingual sites for each implant from the reference line (RL) of the implant platform immediately after implant placement and 12 months follow up visits. All measurements will be made utilizing a coDiagnostiX software used at University of Kentucky College of Dentistry. Marginal bone changes around implants for each site (i.e., Mesial, Distal, Buccal, and Lingual) will be digitally analyzed using the software and statistically analyzed and compared between groups utilizing SPSS software.	12 months
Osstell Value Assessment	Osstell® RFA (Resonance Frequency Analysis) values will be recorded immediately after implant placement, 3 months, and 12 months follow up visits to report implant stability during the healing time. RFA values for each implant will be statistically analyzed and compared between and within groups utilizing SPSS software.	12 months
3D Printed Models Assessment	3D printed models will be generated from intraoral scan prior to baseline extraction visit and 3, 12 months follow up. Volumetric changes will be measured and analyzed digitally with compare software.	12 months
Photographic Documentation	Photographic documentation will be made using a digital camera for each visit to clinically evaluate the peri-implant tissue healing response around implants with immediate vs. early placements.	12 months

Collaborators and Investigators

• Sponsor: Ahmad Kutkut
• Collaborators: Straumann USA
• Investigators: Principal Investigator: Ahmad KutKut, DDS, MS, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dental Implant; Bone Graft; Molar; Extraction; Immediate; Sockets
• Other Study ID Numbers: 55344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes