View clinical trials related to Gingival Diseases.
Filter by:This study will examine the composition of dental plaque-a naturally occurring substance that sticks to the teeth and can cause tooth decay and gum disease. A better understanding of how plaque builds up in the mouth may help in developing improved ways of controlling it. Healthy normal volunteers between the ages of 18 and 65 who work at the National Institutes of Health main campus in Bethesda, Maryland, may participate in this study. Candidates will be screened for eligibility with a medical and dental history. This study involves a maximum of five visits to the dental clinic. At the first visit, participants will have a dental examination, and a mold will be made of the mouth. To make the mold, a small plastic tray containing impression material will be placed in the volunteer's mouth and held in place for about 2 minutes to set. The tray will then be removed and a mold will be made from the impression. The mold will be used to make the mouthpiece used in study 1, described below, and the tooth fittings used in study 2, also described below. Volunteers will participate in one of these two studies. Study 1. Volunteers in study 1 will have their mouthpiece checked at the second visit, have a teeth cleaning, and have the mold put in place. The mouthpiece will be worn for up to 8 hours, during which time soft foods can be eaten. Mouthwash should not be used while the device is in place. At the volunteer's third (last) visit, the mouthpiece will be removed and the volunteer will spit into a tube to collect saliva for examination for bacteria. Study 2. Volunteers in study 2 will have their teeth cleaned at the second visit and the tooth fittings placed onto the back teeth with a dental adhesive. The fittings will be worn for up to 72 hours, during which time volunteers can eat a regular diet and brush their teeth. Mouthwash should not be used while the fittings are in place. At the third, fourth and fifth visits, some of the fittings will be removed and, if necessary, the tooth surface will be polished. The last of the fittings will be removed at the fifth visit and the volunteer will spit into a tube to collect saliva for examination for bacteria.
In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to 57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for local delivery to maximize the drug exposure to critical oral target tissues while minimizing gastric and systemic exposure to the drug. All responses will be determined at the three month completion of trial using the response criteria developed at MD Anderson Cancer Center. The drug will be given for three months and then all the patients will be followed for one additional month off all oral treatment to observe for late side effects. Based on the analysis of oral exam and photographically documented change in the pretreatment area of leukoplakia, the response of all patients will be determined. The evaluation of the outcome will include a measurable secondary endpoint consisting of an assessment of histological change as determined by serial punch biopsies of the oral cavity. In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at baseline, at one month follow up or at study conclusion. In the residual tissue, other bioassays will be evaluated to determine their suitability as intermediate endpoint markers. The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a cooperative group-type setting) may be the next validation step.