Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01944267
Eligibility Criteria:
Inclusion Criteria:
* Patient scheduled for 2nd stage implant surgery at the periodontology clinic of TUSDM.
* Inadequate keratinized tissue (0.1mm- \<2mm of buccal keratinized mucosa prior to the time of 2nd stage surgery) at the implant site. \[4\]
* Adequate depth of buccal vestibule (\>7 mm from the crest of ridge, measured at the center of surgical area) to accommodate gain of keratinized mucosa width.
Exclusion Criteria:
* Lack of keratinized mucosa on the area of implant.
* Autoimmune conditions which may interfere with soft tissue healing in oral cavity, e.g., pemphigus vulgaris, phemphigoid
* Infectious disease (self-reported - HIV, tuberculosis or hepatitis)
* Pregnant patients, as part of TUSDM standard of care not to treat for non-emergency surgical procedures
* Uncontrolled diabetes, defined as HbA1c \>=7, values measured within six months
* Previous gingival grafting procedure on the area.
* Smoking (\>3 cigarettes per day)
* Subjects with known hypersensitivity to study materials or objection to use of porcine material (religious or cultural reasons)
* Known allergy to codeine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01944267
Study Brief:
Protocol Section:
NCT01944267