Procedures for Improving the Mucosa Around Implants
Completed · Not applicable
Conditions studied: Keratinized Mucosa, Dental Implants
In brief
This research study is looking at three different procedures for improving the oral mucosa (membrane) around dental implants. The three procedures will be the standard procedure, the standard procedure with the use of tissue harvested from the mouth and the standard procedure with the use of Mucograft membrane product. An advantage claimed by the Mucograft manufacturer is increased patient comfort due to lack of tissue harvesting from the mouth. Pain and discomfort levels will be evaluated for each of the procedures. Gain in oral mucosa and the visual will also be evaluated.
Key facts
- Study ID
- NCT01944267
- Run by
- Tufts University
- People needed
- 30
- Starts
- 2013-10-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-09-24
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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