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NCT Number: NCT07512245

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

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

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Key information

Conditions

Acellular Dermal Matrix Alveolar Mucosa

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Phase I dental implant placement with acellular dermis

Procedure

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

Phase II dental implant uncovery with acellular dermis

Procedure

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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)

Study contacts

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

Maria Geisinger, DDS, MS

CONTACT

[email protected]

205-934-4984

Sarah Startley, DMD

CONTACT

[email protected]

205-975-8711

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Jun 25, 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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