RECRUITING

Implant Phenotype Modification Via GBR and ADM

Description

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.

Conditions

Horizontal Ridge Deficiency
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Related Conditions:

Horizontal Ridge Deficiency

Study Overview

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Study Details

Study 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.

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

Implant Phenotype Modification Via GBR and ADM

Condition
Horizontal Ridge Deficiency
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Muhammad Saleh, BDS, MSD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2026-09-01