Assessment of Two Soft Tissue Augmentation Using Acellular Dermis Around Dental Implants

NCT07512245 | Not Yet Recruiting

• 2 other identifiers: IRB-300016380UAB Periodontology
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare soft tissue grafting with acellular dermis at Phase I or Phase II dental implant surgery.

Conditions

Acellular Dermal Matrix; Alveolar Mucosa

Keywords

soft tissue graft

Outcome Measures

Primary Outcomes (5)

• Width of buccal keratinized tissue at dental implant sites

  Width of buccal keratinized tissue at dental implant sites as measured with a calibrated UNC-15 periodontal probe from the gingival margin to the mucogingival junction.

  From baseline to 6 months

• Thickness of buccal keratinized tissue 2mm from the gingival margin of the dental implant sites

  Thickness of buccal keratinized tissue 2mm from the gingival margin as measured with an endodontic reamer with a stopper

  From baseline to 6 months

• Vertical height of peri-implant soft tissues

  Vertical height of peri-implant soft tissues as measured with an endodontic reamer and stopper after local anesthesia delivery and calibrated periodontal probe from gingival margin to the alveolar crest at the implant sulcus in a parallel manner.

  From Baseline to 6 months

• Radiographic marginal bone loss

  Radiographic marginal bone loss as measured using digital tool and calibrated parallel radiographic images

  From baseline to 6 months

• Patient centered outcomes using the Visual Analog Scale (VAS)

  Patient centered outcomes including pain, bleeding, swelling, change in daily activities using the Visual Analog Scale (VAS). This measurement ranges from 0-10 (0 being better and 10 being worse)

  4 weeks

Study Arms (2)

Phase I dental implant placement with acellular dermis

ACTIVE COMPARATOR

After dental implant placement, soft tissue augmentation using acellular dermis will be performed

Procedure: Phase I dental implant placement with acellular dermis

Phase II dental implant uncovery with acellular dermis

EXPERIMENTAL

Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed

Procedure: Phase II dental implant uncovery with acellular dermis

Interventions

Phase II dental implant uncovery with acellular dermis PROCEDURE

Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed

Phase II dental implant uncovery with acellular dermis

Phase I dental implant placement with acellular dermis PROCEDURE

After dental implant placement, soft tissue augmentation using acellular dermis will be performed

Phase I dental implant placement with acellular dermis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• At least 18 years old
• Must be a patient of the UAB Dental School
• Able to read and understand informed consent document
• Patients presenting with a single edentulous site planned for dental implant placement deemed deficient in soft tissue peri-implant phenotype (\> 2mm width of keratinized tissue, \< 1mm marginal soft tissue thickness, and/or \> 2mm vertical soft tissue height)
• Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of edentulous site planned for dental implant placement.
• No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.

You may not qualify if:

• Non-English speaking
• Less than 18 years old
• Smokers/tobacco users (\>10 cigarettes/day)
• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
• Edentulous sites treatment planned for dental implant placement with adequate implant site soft tissue quality/quantity (\> 2mm width of keratinized tissue, \> 1mm marginal soft tissue thickness, and/or \> 2mm vertical soft tissue height).
• Absence of adjacent teeth/implants on either side of the tooth to be extracted and/or edentulous sites where 2 or more adjacent implants are planned.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Study Officials

• Maria L Geisinger, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Geisinger, DDS, MS

CONTACT

205-934-4984; miagdds@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711; ss1971@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)