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Bone Graft

Bio-Oss Collagen Graft for Tooth Loss

N/A

Waitlist Available

Led By Theodoros Katsaros

Research Sponsored by Gustavo Avila-Ortiz DDS, MS, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18 years or older

Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post implant loading

Awards & highlights

Study Summary

This trial will evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen over a 3-6-9 month period following tooth extraction in single-rooted tooth sites.

Who is the study for?

This trial is for adults needing a single-rooted tooth (not mandibular incisors) extracted and replaced with an implant. Candidates should be in good health, able to undergo dental procedures, and willing to sign consent. Exclusions include severe bone diseases, significant organ impairments, heavy smokers, pregnant or nursing women, those on certain medications affecting bone metabolism.Check my eligibility

What is being tested?

The study tests how well the Bio-Oss Collagen® graft aids healing after tooth extraction at different intervals: 3, 6, and 9 months. Participants are divided into three groups; each group receives implants at different times post-extraction (12, 24 or 36 weeks), followed by evaluations including CBCT scans and biopsies.See study design

What are the potential side effects?

Potential side effects may include discomfort at the graft site, swelling or bruising around the area of surgery. There could also be risks associated with anesthesia during surgical procedures.

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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My tooth extraction site has intact walls or only one side is partially missing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post implant loading

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years post implant loading

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post implant loading for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Implant survival

Secondary outcome measures

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months

% of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Implant placement 3 mo. after tooth ext.Experimental Treatment1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext.

Group II: Implant placement 9 mo. after tooth ext.Active Control1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext.

Group III: Implant placement 6 mo. after tooth ext.Active Control1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Gustavo Avila-Ortiz DDS, MS, PhDLead Sponsor

3 Previous Clinical Trials

59 Total Patients Enrolled

1 Trials studying Tooth Loss

17 Patients Enrolled for Tooth Loss

Theodoros Katsaros, DDS, MSDLead Sponsor

University of IowaLead Sponsor

446 Previous Clinical Trials

879,460 Total Patients Enrolled

2 Trials studying Tooth Loss

20 Patients Enrolled for Tooth Loss

Media Library

Bio-Oss Collagen (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03659617 — N/A

Tooth Loss Research Study Groups: Implant placement 3 mo. after tooth ext., Implant placement 9 mo. after tooth ext., Implant placement 6 mo. after tooth ext.

Tooth Loss Clinical Trial 2023: Bio-Oss Collagen Highlights & Side Effects. Trial Name: NCT03659617 — N/A

Bio-Oss Collagen (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03659617 — 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 current openings in this clinical trial?

"The clinicaltrials.gov database indicates that this research study is no longer recruiting patients, with the initial posting from December 10th 2018 and last update on March 25th 2022. However, 33 other trials are still open for enrollment at this time."

Answered by AI

Do I satisfy the requirements for participating in this clinical research?

"This research project is recruiting 42 individuals between 18-95 years of age who have lost one or more teeth. The applicants must be in good physical and mental health, capable of undergoing dental treatments like tooth extraction and implant placement, regardless of gender. Moreover, the extractions socket walls should either be intact or feature no more than half a bony wall (buccal/lingual) dehiscence for consideration."

Answered by AI

Are elderly patients permitted to join this research effort?

"Applicants eligible for this medical trial must be between the ages of 18 and 95. Additionally, there are 4 clinical trials available for minors and 29 studies open to seniors over 65 years old."

Answered by AI