Procedures for Improving the Mucosa Around Implants

Dental Implants Clinical Trial

Official title: Apically Positioned Flap, Free Gingival Graft and Apically Positioned Flap With Collagen Matrix Around Dental Implants

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Dental Implants
• Keratinized Mucosa

• NCT number: NCT01944267
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: May 2016