|- candidate number||3273|
|- NTR Number||NTR1312|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-mei-2008|
|- Secondary IDs||NL22051.068.08 |
|- Public Title||Formation of harmful nitrosamines in patients suffering from periodontitis.|
|- Scientific Title||Formation of nitrosamines in patients with periodontitis.|
|- ACRONYM||Periodontitis and nitrosamine formation|
|- hypothesis||We hypothesize that nitrosamine formation in periodontitis patients is higher compared to healthy controls. |
|- Healt Condition(s) or Problem(s) studied||Periodontitis, Nitrosamines |
|- Inclusion criteria||Both male and female participants will be included between 30 and 50 years of age either suffering from periodontitis or being healthy with regards to dental status.|
|- Exclusion criteria||- Smokers will be excluded from participation. |
- In addition, certain medical conditions can predispose subjects to the development of periodontitis. These conditions include:
1. Diabetes mellitus
3. Inflammatory bowel disease
4. Down's syndrome
People suffering from these conditions will be excluded as well.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jul-2008|
|- planned closingdate||1-dec-2008|
|- Target number of participants||40|
|- Interventions||No intervention will be performed. Just a one time sampling of urine, saliva, a dental bacterial sample and an X-ray picture of the teeth will be made.|
|- Primary outcome||Difference in concentration of nitrosamines in saliva and urine samples between periodontitis patients and healthy controls.|
|- Secondary outcome||Difference in concentration of nitrate and nitrite in saliva and urine samples between periodontitis patients and healthy controls. Analysis of differences in microflora composition of bacterial samples from dental pocket between periodontitis patients and healthy controls. |
|- Timepoints||Only one measurement will be performed. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C.J.M.W. Aardening|
|- CONTACT for SCIENTIFIC QUERIES||Drs. D.G.A.J. Hebels|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM)|
|- Brief summary||Rationale: Periodontal disease (or periodontitis) has been linked to the development of cancer, including tongue cancer and pancreatic cancer. An increased formation of carcinogens, namely nitrosamines, is likely to contribute significantly to this association. The inflammatory process and increased numbers of nitrate-reducing bacteria are expected to stimulate the formation of nitrosamines. We therefore hypothesize that nitrosamine formation in periodontitis patients is higher compared to healthy controls. |
Objective: Our main objective is to demonstrate an increased formation of nitrosamines in periodontitis patients compared to healthy controls by analyzing saliva and urine samples for these compounds. In addition we will attempt to link nitrosamine concentrations in saliva and urine to oral microflora status and nitrate/nitrite concentrations.
Study design: We will perform a cross-sectional study in periodontitis patients and healthy controls. Each participant will be asked to donate a saliva and urine sample, a bacterial dental pocket sample and undergo an X-ray picture of the teeth during a one-time visit to the periodontist practice.
Study population: For the study we require periodontitis patients and healthy controls to participate. Both male and female participants will be included between 30 and 50 years of age.
Main study parameters/endpoints: Determine if there is a difference in concentration of nitrosamines in saliva and urine samples between periodontitis patients and healthy controls.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will help to gain insight in the formation of carcinogenic nitrosamines in periodontitis patients possibly contributing to the increased cancer risk in this group. Upon signing an informed consent form an appointment will be made for a short visit to the periodontist practice. During this visit to the practice a bacterial sample will be collected for analysis of microflora composition. An X-ray picture of the teeth will be taken for analysis by the periodontist. Saliva and urine samples can be collected in the practice and will be analyzed in the lab for presence of nitrosamines and nitrate/nitrite. The entire visit will last approximately one hour. Burden for participants will be minimal and the risks associated with participation can be considered negligible.
|- Main changes (audit trail)|
|- RECORD||8-mei-2008 - 26-jun-2008|