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Bone Substitute
Bone Graft Surgery for Peri-Implantitis
N/A
Waitlist Available
Research Sponsored by Andrea Ravida
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 12 months
Awards & highlights
Study Summary
This trial will compare 2 surgical methods of treating peri-implantitis, to see which is more effective. Bone grafts and membranes may be used.
Who is the study for?
This trial is for adults over 18 with peri-implantitis, who are patients at the University of Pittsburgh Periodontics Department. They must have good oral hygiene scores and be systemically healthy. Excluded are those with uncontrolled oral diseases, allergies to dental anesthetics, diabetes, certain medication histories, pregnant or lactating women, heavy smokers, and individuals with conditions affecting healing.Check my eligibility
What is being tested?
The study compares two surgical treatments for peri-implantitis: one using a bone graft alone (InterOss Collagen), and another combining the bone graft with a resorbable collagen membrane (InterOss Collagen Guide). The goal is to see which method better improves bone defects around dental implants.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, swelling, infection risk increase due to surgery or materials used like the bone xenograft or collagen membrane. Individual reactions can vary based on personal health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Peri-Implant Bone Defect Fill
Clinical Peri-Implant Bone Defect Resolution
Peri-Implant Bleeding on Probing
+3 moreSecondary outcome measures
Patient Reported Pain Outcomes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bone grafting with collagen membraneExperimental Treatment1 Intervention
This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft.
Group II: Bone grafting without collagen membraneActive Control1 Intervention
This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft.
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Who is running the clinical trial?
SigmaGraft Inc.UNKNOWN
Andrea RavidaLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have untreated cancer or gum disease in my mouth.I am not on medications that affect healing or bone integration.I have had chemotherapy or radiation for head or neck cancer within the last 5 years.I am taking or have taken medications that can cause gum growth.I am generally healthy aside from my current condition.I have gum disease around my dental implant with deep cleaning needs.I have been diagnosed with diabetes.I am 18 years old or older.I do not have conditions like HIV, Paget's disease, or osteoporosis that could affect healing after surgery.I am not pregnant, breastfeeding, unsure of my pregnancy status, or planning to become pregnant within a year.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Bone grafting with collagen membrane
- Group 2: Bone grafting without collagen membrane
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.
Peri-Implantitis Patient Testimony for trial: Trial Name: NCT05699343 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participation in this clinical experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this experiment is still ongoing since its inception on January 1st 2023 and last modified date of January 16th 2023. The study requires 52 individuals to join at a single clinic site."
Answered by AI
What is the scope of participation in this medical experiment?
"Correct. The clinical trial's listing on clinicaltrials.gov indicates that recruitment is ongoing, with the initial post having been made on January 1st 2023 and the last update being issued a fortnight later. This medical research requires 52 individuals to be enrolled from one centre."
Answered by AI
Who else is applying?
What state do they live in?
New York
Texas
Pennsylvania
Other
What site did they apply to?
University of Pittsburgh School of Dental Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I need implants for my entire top set of teeth. I was needing to get implants for my missing teeth.
PatientReceived 1 prior treatment
I.tired of not smiling or covering my mouth when I do smile. I could only eat curtain foods due to not having teeth.
PatientReceived no prior treatments
I feel i am a good candidate for this study. I have some teeth missing, and some that are not in good shape on my upper jaw. I have one tooth missing on my lower jaw.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the screening? is this a study for only 1 implant? Do you provide the denture for the implants too?
PatientReceived 1 prior treatment
How long is the process? When will you know if you are illegible? How do I get to this location and who is paying for the travel ? Where do I stay while I'm there ?
PatientReceived no prior treatments
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