Assessment of Two Soft Tissue Augmentation Using Acellular Dermis Around Dental Implants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham
About this trial
This study aims to compare soft tissue grafting with acellular dermis at Phase I or Phase II dental implant surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English speaking
At least 18 years old
Must be a patient of the UAB Dental School
Able to read and understand informed consent document
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Phase I dental implant placement with acellular dermis
Procedure/SurgeryAfter dental implant placement, soft tissue augmentation using acellular dermis will be performed
Phase II dental implant uncovery with acellular dermis
Procedure/SurgeryDental implant uncovery, soft tissue augmentation using acellular dermis will be performed
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Phase I dental implant placement with acellular dermisActive comparator 1 intervention
Group B: Phase II dental implant uncovery with acellular dermisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to 6 months2
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
Time frame
From baseline to 6 months3
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.
Time frame
From Baseline to 6 months4
Radiographic marginal bone loss
Radiographic marginal bone loss as measured using digital tool and calibrated parallel radiographic images
Time frame
From baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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