Procedures for Improving the Mucosa Around Implants
Condition: Keratinized Mucosa; Dental Implants
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Apically positioned flap; Free Gingival Graft; apically positioned flap with Mucograft
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Standard TUSDM Periodontology Clinic procedures will be followed. Local anesthesia will be achieved. Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
No vertical incision will be made Gingiva coronal to horizontal incision will remain intact Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures.
Prepared surgical area will be measured apico-coronally and mesio-distally.; Standard Clinic procedures followed. Local anesthesia achieved. Center of implant fixtures located. Crestal incision thru center of fixture will be made.
Implant fixture uncovered and healing abutment/s inserted. Horizontal incision at approx 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
No vertical incision made. Gingiva coronal to horizontal incision remains intact.
Partial thickness flap prepared and displaced apically approximately 7mm from horizontal incision; secured with sutures. Prepared recipient bed measured apico-coronally and mesio-distally. Masticatory mucosa from palate of treating side (Right or Left) harvested according to size measured from recipient bed with width of approximately 5mm at line of measurement. Harvested graft material will be transplanted on recipient bed, lined with initial horizontal incision line with sutures; Standard TUSDM Periodontology Clinic procedures followed. Local anesthesia achieved.
Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
No vertical incision will be made. Gingiva coronal to horizontal incision will remain intact. Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures.
Prepared recipient bed will be measured apico-coronally and mesio-distally. Mucograft material will be prepared according to the manufacturer's instruction and trimmed as the size measured from the recipient and be placed and secured on the recipient bed with sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment