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New treatment option for Horizontal Ridge Deficiency
Official title Implant Phenotype Modification Via GBR and ADM
ClinicalTrials.gov ID: NCT07082244
What this study is testing
- What it's testing
- Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- people with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of...
- people must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and...
- people must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
- The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
You likely can't join if
- Presence of uncontrolled and/or untreated periodontal disease.
- Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
- people taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates...
- people with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
- Allergy to the graft materials.
- Pregnant people or individuals who self-report as attempting to become pregnant.
See the full eligibility criteria
- Age ≥ 18 years.
- people with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II.
- people must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary...
- people must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
- The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
- Seibert class I deficiency (Seibert, 1983)
- Patients willing to sign the informed consent.
- Presence of uncontrolled and/or untreated periodontal disease.
- Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
- people taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head...
- people with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
- Allergy to the graft materials.
- Pregnant people or individuals who self-report as attempting to become pregnant.
- Patient's unwilling to sign the informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.