The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Single application; split-mouth design
Single application; split-mouth design
Perio Health Professionals, PLLC
Houston, Texas, United States
Overall Rate of Adverse Events (AEs)
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Time frame: 6-month
Periodontal Health Measures
Time frame: 6-months
Aesthetic Measures
Time frame: 6-months
Post-Surgical Subject Comfort Measures
Time frame: 4-weeks
Subject Preference Measures
Time frame: 6-months
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