Procedures for Improving the Mucosa Around Implants

Experimental Design

The study design for this research project will be a single centered, prospective randomized
controlled trial. Subjects will be Tufts University School of Dental Medicine Department of
Periodontology patients.

Sample Size and Statistical Analysis

There will be up to 22 subjects in each group, with a total of up to 66 subjects in the
study. Up to 80 subjects will be enrolled in order to have 66 subjects completed the study.
The calculation is based on 2 point difference in VAS pain and discomfort survey to have 80%
power, while setting α=0.025 to adjust for the two primary outcomes (pain and discomfort)
which gives 19 per each group. However, considering a 15% drop out rate, up to 22 subjects
for each group will be recruited.

Data collected for analysis will be 10 point VAS from subjects' survey forms for the primary
outcome. And 10 point VAS from esthetic evaluation, gain of keratinized mucosa measured by
periodontal probe in millimeters with stent will be data for secondary outcome.

For all variables, normality will be assessed using the Kolmogorov-Smirnov test. If the
assumptions of normality hold, then means and standard deviations will be reported and the
relationship between treatment arm and the outcome will be tested using one-way ANOVA. If the
assumptions of normality do not hold, then medians and interquartile ranges will be reported
and relationships will be tested using the Kruskal-Wallis test. If the initial analyses are
significant, then the post hoc pair wise comparisons will be made using either independent
sample t-tests or Mann-Whitney U-tests. When patients are lost to follow-up, their
information will be excluded from the analyses. To account for the multiple comparisons, the
Bonferroni correction will be implemented. Thus, all p-values less than 0.025 will be
considered statistically significant. Analyses will be performed using SAS, Version 9.2 (SAS
Institute, Cary, NC).

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