Implant Phenotype Modification Via GBR and ADM

Official title

Phenotype Modification Via Guided Bone Regeneration and Acellular Dermal Matrix Simultaneous to Delayed Implant Placement: A Double Arm Randomized Controlled Clinical Trial.

Overview

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

• 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.

Primary outcome measures

• Horizontal linear change of the buccal bone [Time frame: 6 months]

Secondary outcome measures (6)

• The volumetric changes of the facial soft tissue [Time frame: 6 months]
• The vascular changes of the facial soft tissue [Time frame: 6 months]
• Peri-implant health, as defined by clinical attachment level. [Time frame: 6 months]
• Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS) [Time frame: 6 months]
• Clinician-reported overall treatment effectiveness [Time frame: 6 months]
• Histological bone density [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07082244 · HUM00262601

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗