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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Peri-Implant Bone Defect Fill
Clinical Peri-Implant Bone Defect Resolution
Peri-Implant Bleeding on Probing
+3 moreSecondary study objectives
Patient Reported Pain Outcomes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
SigmaGraft Inc.UNKNOWN
Andrea RavidaLead Sponsor
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Peri-Implantitis
90 Patients Enrolled for Peri-Implantitis
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