Dental Implants Clinical Trial
Official title:
Apically Positioned Flap, Free Gingival Graft and Apically Positioned Flap With Collagen Matrix Around Dental Implants
NCT number | NCT01944267 |
Other study ID # | IRB 10893 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | May 2016 |
Verified date | September 2018 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2016 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts University School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain and discomfort survey | A survey using VAS scale will be performed from the subjects at 10-14 days follow up visit. | 10 to 14 days follow up | |
Secondary | Evaluation of full mouth gingival condition (periodontal parameters) | Subject's full mouth gingival condition will be evaluated using a periodontal probe. The following will be assessed at 4 sites/tooth: Plaque index (Modified O'Leary Plaque Index) and gingival index (Löe and Silness 1963). The following will be assessed at 6 sites/tooth: Probing depth (mm), Bleeding on probing (yes/no), Recession (mm), and Clinical attachment level (mm). Mobility (Miller classification) and mucogingival deformities will also be evaluated. Plaque control with oral hygiene instruction will be reinforced. | At 3-month and 6-month follow up appointments. |
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