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Implant
Definitive abutment for Osteoporosis
N/A
Waitlist Available
Led By Joseph Kan, DDS, MS
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (prior to surgical implantation), and 12 months after surgical implantation
Awards & highlights
Study Summary
This trial will study whether connecting an abutment to an implant at the time of placement affects bone level changes in the back of the jaw and below the lower lip.
Eligible Conditions
- Osteoporosis
- Gum Recession
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline (prior to surgical implantation), and 12 months after surgical implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (prior to surgical implantation), and 12 months after surgical implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in bone level between baseline surgery and 12 months
Secondary outcome measures
Level of radiolucency after implant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Test groupExperimental Treatment1 Intervention
Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Group II: Control groupActive Control1 Intervention
Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Definitive abutment
2019
N/A
~20
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,969 Total Patients Enrolled
Nobel BiocareIndustry Sponsor
23 Previous Clinical Trials
2,287 Total Patients Enrolled
Joseph Kan, DDS, MSPrincipal Investigator - Loma Linda University School of Dentistry
Loma Linda University
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have any dental work or devices that interfere with your ability to close your mouth properly.You have a history of smoking or currently smoke.You grind or clench your teeth habitually, now or in the past.Your bones need to be strong and big enough to hold an implant that is at least 4.3 mm wide and 8mm long.You have good teeth cleaning habits.You are missing two or more teeth in the back of your mouth (excluding wisdom teeth), and the area where the teeth were removed has fully healed.You must have enough space between your teeth (at least 8mm) to receive a dental restoration procedure.You have a history of alcohol or drug dependency, or any medical, physical, or psychological condition that could impact the surgery or follow-up appointments.You have received radiation treatment in the past on your head and neck area.You require additional bone support during dental implant surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Test group
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.
Osteoporosis Patient Testimony for trial: Trial Name: NCT04043286 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are partaking in this research project?
"Indeed, the online registry shows that this medical experiment is currently seeking participants. It was initially posted on September 30th 2019 and had its latest update on April 13th 2022. 19 individuals need to be recruited from one site for this trial."
Answered by AI
Are there any active enrolment slots available for this clinical trial?
"Affirmative. The trial's entry on clinicaltrials.gov confirms that this medical study is presently seeking volunteers, with the initial posting having been made on September 30th 2019 and most recently updated April 13th 2022. 19 patients are needed at 1 single facility for enrolment in the research project."
Answered by AI
Who else is applying?
What state do they live in?
Utah
California
Georgia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Loma Linda University
How many prior treatments have patients received?
2
3+
What questions have other patients asked about this trial?
Is this for a full mouth restoration?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have problem with my gums receding. I have been to dentist after dentist trying to do something about my teeth. Each one I usually apologize for waisting their time and walk out in tears because I cannot afford to do all that needs to be done.
PatientReceived 1 prior treatment
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