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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
Study individuals will be included if they met the following criteria: (a) one or more peri-implant sites with PPD ≥6 mm combined with BOP/suppuration, and (b) peri-implant marginal bone loss, defined as a crater like defect ≥3 mm as assessed from intra- oral radiographs, (c) Infrabony circumferential defect of more than 270° determined by CBCT, (d) crown not possible to retrieve before surgery
age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.
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I am generally healthy with no major illnesses.
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I have gum disease around my dental implant with deep cleaning needs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more
Secondary outcome measures
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

Media Library

InterOss Collagen (Bone Substitute) Clinical Trial Eligibility Overview. Trial Name: NCT05699343 — N/A
Peri-Implantitis Research Study Groups: Bone grafting with collagen membrane, Bone grafting without collagen membrane
Peri-Implantitis Clinical Trial 2023: InterOss Collagen Highlights & Side Effects. Trial Name: NCT05699343 — N/A
InterOss Collagen (Bone Substitute) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05699343 — N/A
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 was needing to get implants for my missing teeth. 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 1 prior treatment
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
~33 spots leftby Jan 2026