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Not yet recruiting NCT07512245

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

No phase Interventional Acellular Dermal Matrix Alveolar Mucosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phase I dental implant placement with acellular dermis, Phase II dental implant uncovery with acellular dermis.
Who it may be relevant to
Registry conditions: Acellular Dermal Matrix, Alveolar Mucosa. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Procedure Phase I dental implant placement with acellular dermis
    After dental implant placement, 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

Primary outcome measures

  • Width of buccal keratinized tissue at dental implant sites [Time frame: 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]
  • Vertical height of peri-implant soft tissues [Time frame: From Baseline to 6 months]
  • Radiographic marginal bone loss [Time frame: From baseline to 6 months]
  • Patient centered outcomes using the Visual Analog Scale (VAS) [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07512245 · IRB-300016380 · UAB Periodontology

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗