RECRUITING

Implant Phenotype Modification Via GBR and ADM

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-01

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07082244

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

David Dunbar, DDS

CONTACT

734-763-3346

dgdunbar@umich.edu

Alice Ou, RDH, MS

CONTACT

734-763-3346

aliceou@umich.edu

Principal Investigator

Muhammad Saleh, BDS, MSD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Horizontal Ridge Deficiency