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Bone Adhesive
Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability
N/A
Waitlist Available
Research Sponsored by LaunchPad Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Require tooth extraction and replacement with dental implant;
Planned "implant site" must have 1 adjacent tooth;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new bone adhesive called TN-SM to stabilize dental implants right after tooth removal. It aims to make the process faster by eliminating the need for bone grafting. TN-SM is a new injectable adhesive that has been evaluated for quick implant stabilization in earlier research.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a tooth removed and replaced with an implant.
Select...
The tooth where I plan to get an implant has one neighboring tooth.
Select...
I have enough bone for a dental implant.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Implant Success (Modified Buser Criteria)
Secondary study objectives
Adverse Events (Serious, Device Related)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TetraniteExperimental Treatment1 Intervention
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tetranite
2019
N/A
~20
Find a Location
Who is running the clinical trial?
LaunchPad MedicalLead Sponsor
1 Previous Clinical Trials
RevBioLead Sponsor
3 Previous Clinical Trials
35 Total Patients Enrolled
George Kay, DMDStudy DirectorRevBio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.My jawbone is tall enough for safe dental implant surgery.I need a tooth removed and replaced with an implant.Do not have opposing dentition.I have enough bone for a dental implant.You have an ASA I or II score.The tooth where I plan to get an implant has one neighboring tooth.I am committed to studying and following-up on this issue.
Research Study Groups:
This trial has the following groups:- Group 1: Tetranite
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.