Horizontal Ridge Deficiency
Conditions
Brief summary
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.
Detailed description
The study will treat patients that need a single implant at a previously edentulous site (\>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.
Interventions
PROCEDUREDental implant placement
Participants will have a dental implant placed at a toothless site
PROCEDUREGuided bone regeneration with collagen membrane
Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane.
PROCEDUREGuided bone regeneration with acellular dermal matrix.
Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Subjects 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. * Subjects 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 premolars, canines, and incisors. * Subjects 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.
Exclusion criteria
* Presence of uncontrolled and/or untreated periodontal disease. * Patients currently smoking cigarettes, cannabis, and electronic cigarettes. * Subjects 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 and neck radiation, chemotherapy within the last 12 months, among others. * Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease. * Allergy to the graft materials. * Pregnant subjects or individuals who self-report as attempting to become pregnant. * Patient's unwilling to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal linear change of the buccal bone | 6 months | Radiographic changes of bone level in mm based on cone-beam computed tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The volumetric changes of the facial soft tissue | 6 months | Volumetric changes in mm\^3 based on intraoral digital scans |
| The vascular changes of the facial soft tissue | 6 months | Vascular changes in mm\^3 based on ultrasound scans |
| Peri-implant health, as defined by clinical attachment level. | 6 months | Changes in clinical attachment level measurements in mm |
| Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS) | 6 months | Difference in survey results |
| Clinician-reported overall treatment effectiveness | 6 months | Scale from 1 (Poor) to 5 (Excellent) |
| Histological bone density | 6 months | Histomorphometry |
Countries
United States
Contacts
CONTACTDavid Dunbar, DDS
CONTACTAlice Ou, RDH, MS
PRINCIPAL_INVESTIGATORMuhammad Saleh, BDS, MSD
University of Michigan
Outcome results
None listed