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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
David Dunbar, DDS
dgdunbar@umich.edu
734-763-3346
Backup
Alice Ou, RDH, MS
aliceou@umich.edu
734-763-3346
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Guided bone regeneration
Guided bone regeneration with collagen membrane
Experimental: Guided bone regeneration with Phenotype modification.
Guided bone regeneration with an allogenic dermal matrix
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov