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

March 30, 2026 updated by: Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham

Assessment of Two Soft Tissue Augmentation Protocols Using Acellular Dermis for Augmentation of Soft Tissue Quantity and Quality Around Dental Implants

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This proposed study would allow us to assess the use of two different timing protocols for soft tissue augmentation in real-world scenarios to improve clinicians' understanding of optimal protocols for soft tissue grafting and their impact on surgical outcomes, patient-reported outcomes, and long-term implant health.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarah Startley, DMD
  • Phone Number: 205-975-8711
  • Email: ss1971@uab.edu

Study Contact Backup

  • Name: Maria Geisinger, DDS, MS
  • Phone Number: 205-934-4984
  • Email: miagdds@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham
        • Contact:
          • Sarah Startley, DMD
          • Phone Number: 205-975-8711
          • Email: ss1971@uab.edu
        • Contact:
          • Maria Geisinger, DDS, MS
          • Phone Number: 205-934-4984
          • Email: miagdds@uab.edu
        • Principal Investigator:
          • Maria L Geisinger, DDS, MS

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phase I dental implant placement with acellular dermis
After dental implant placement, soft tissue augmentation using acellular dermis will be performed
Procedure: Phase I dental implant placement with acellular dermis
After dental implant placement, soft tissue augmentation using acellular dermis will be performed
Experimental: Phase II dental implant uncovery with acellular dermis
Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed
Procedure: Phase II dental implant uncovery with acellular dermis
Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Width of buccal keratinized tissue at dental implant sites
Time Frame: From baseline to 6 months
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
Time Frame: From baseline to 6 months
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
Time Frame: From Baseline to 6 months
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
Time Frame: From baseline to 6 months
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)
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Maria L Geisinger, DDS, MS, University of Alabama at Birmingham

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 Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-300016380
  • UAB Periodontology (Other Identifier: University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data from this study will not be shared with other researchers outside of our research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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