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Recruiting

NCT Number: NCT07082244

Implant Phenotype Modification Via GBR and ADM

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Alice Ou, RDH, MS

CONTACT

[email protected]

(734) 763-3346

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental implant placement

Procedure

Participants will have a dental implant placed at a toothless site

Guided bone regeneration with collagen membrane

Procedure

Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane.

Guided bone regeneration with acellular dermal matrix.

Procedure

Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.

Primary outcomes

  1. Horizontal linear change of the buccal bone

    Time frame: 6 months

    Radiographic changes of bone level in mm based on cone-beam computed tomography

Secondary outcomes

  1. The volumetric changes of the facial soft tissue

    Time frame: 6 months

    Volumetric changes in mm^3 based on intraoral digital scans

  2. The vascular changes of the facial soft tissue

    Time frame: 6 months

    Vascular changes in mm^3 based on ultrasound scans

  3. Peri-implant health, as defined by clinical attachment level.

    Time frame: 6 months

    Changes in clinical attachment level measurements in mm

  4. Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)

    Time frame: 6 months

    Difference in survey results

  5. Clinician-reported overall treatment effectiveness

    Time frame: 6 months

    Scale from 1 (Poor) to 5 (Excellent)

  6. Histological bone density

    Time frame: 6 months

    Histomorphometry

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Ou, RDH, MS

CONTACT

[email protected]

734-763-3346

David Dunbar, DDS

CONTACT

[email protected]

734-763-3346

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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