Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes.

INTRODUCTION: The impaired host defense system in HIV infection impacts the oral and gastrointestinal microbiota and associated opportunistic infections. Antiretroviral treatment is predicted to partially restore host defenses and decrease the oral manifestation of HIV/AIDS. Well-designed longitudinal studies are needed to better understand the interactions of soluble host defense proteins with bacteria and virus in HIV/AIDS. "Crosstalk" was designed as a longitudinal study of host responses along the gastrointestinal (GI) tract and interactions between defense molecules and bacteria in HIV infection and subsequent therapy. PURPOSE: The clinical core formed the infrastructure for the study of the interactions between the proteome, microbiome and innate immune system. The core recruited and retained study subjects, scheduled visits, obtained demographic and medical data, assessed oral health status, collected samples, and guided analysis of the hypotheses. This manuscript presents a well-designed clinical core that may serve as a model for studies that combine clinical and laboratory data. METHODS: Crosstalk was a case-control longitudinal clinical study an initial planned enrollment of 170 subjects. HIV+ antiretroviral naïve subjects were followed for 9 visits over 96 weeks and HIV uninfected subjects for 3 visits over 24 weeks. Clinical prevalence of oral mucosal lesions, dental caries and periodontal disease were assessed. RESULTS: During the study, 116 subjects (47 HIV+, 69 HIV-) were enrolled. Cohorts of HIV+ and HIV- were demographically similar except for a larger proportion of women in the HIV- group. The most prevalent oral mucosal lesions were oral candidiasis and hairy leukoplakia in the HIV+ group. DISCUSSION: The clinical core was essential to enable the links between clinical and laboratory data. The study aims to determine specific differences between oral and GI tissues that account for unique patterns of opportunistic infections and to delineate the differences in their susceptibility to infection by HIV and their responses post-HAART.

Survival rate of one-piece dental implants placed with a flapless or flap protocol--a randomized, controlled study: 12-month results.

The purpose of this randomized controlled clinical study was to compare the survival of a one-piece anodically oxidized surface implant when placed with a flapless or flap protocol. Bone loss measurements on radiographs and changes in clinical probing depths 1 year post-definitive restoration placement were recorded and compared. Fifty-two of 60 patients (implants) remained in the study at the 1-year follow-up. At the time of final evaluation, no implant was lost in either group. At the time of placement of the definitive restoration, there was a mean mesial and distal bone gain in both groups compared to bone levels present at the time of implant insertion. There were no significant changes in bone levels between placement of the definitive restoration and those recorded 12 months later, and no significant differences in bone levels between the flap or flapless group at 6 or 12 months were noted. No significant differences were seen either in pocket depth or change in pocket depth at 6 and 12 months in the flapless and flap groups. It was therefore concluded that one-piece anodically oxidized surface implants, 1 year post-definitive restoration insertion, had high survival rates (100%) and stable marginal bone and probing depth levels whether a flapless or flap protocol was used for implant insertion.