Implant Phenotype Modification Via GBR and ADM

Purpose

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.

Condition

  • Horizontal Ridge Deficiency

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Guided bone regeneration 		Guided bone regeneration with collagen membrane
  • Procedure: Dental implant placement
    Participants will have a dental implant placed at a toothless site
  • Procedure: Guided bone regeneration with collagen membrane
    Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane.
  • Procedure: Guided bone regeneration with acellular dermal matrix.
    Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.
Experimental
Guided bone regeneration with Phenotype modification. 		Guided bone regeneration with an allogenic dermal matrix
  • Procedure: Dental implant placement
    Participants will have a dental implant placed at a toothless site
  • Procedure: Guided bone regeneration with acellular dermal matrix.
    Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Alice Ou, RDH, MS
(734) 763-3346
aliceou@umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

David Dunbar, DDS
734-763-3346
dgdunbar@umich.edu

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.