Acellular Dermal Matrix, Alveolar Mucosa
Conditions
Keywords
soft tissue graft
Brief summary
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
PROCEDUREPhase I dental implant placement with acellular dermis
After dental implant placement, soft tissue augmentation using acellular dermis will be performed
PROCEDUREPhase II dental implant uncovery with acellular dermis
Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Width of buccal keratinized tissue at dental implant sites | 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. |
| Thickness of buccal keratinized tissue 2mm from the gingival margin of the dental implant sites | From baseline to 6 months | Thickness of buccal keratinized tissue 2mm from the gingival margin as measured with an endodontic reamer with a stopper |
| Vertical height of peri-implant soft tissues | 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. |
| Radiographic marginal bone loss | From baseline to 6 months | Radiographic marginal bone loss as measured using digital tool and calibrated parallel radiographic images |
| Patient centered outcomes using the Visual Analog Scale (VAS) | 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) |
Countries
United States
Contacts
CONTACTMaria Geisinger, DDS, MS
CONTACTSarah Startley, DMD
PRINCIPAL_INVESTIGATORMaria L Geisinger, DDS, MS
University of Alabama at Birmingham
Outcome results
None listed