German Clinical Trials Register

Acronym/abbreviation of the study

DSCM

URL of the study

No Entry

Brief summary in lay language

Sample collection started on 9 May 2016 and finished on 19 September 2016. However, the whole study (incl. analyses, Duraphat treatment, and both of the Results & Discussion writing) was terminated on 16 October 2017. Challenges of the subject: 1- 1- DS subjects represent a still unsolved biological/clinical paradox and are usually combined with nutritional diseases. 2- As soon as, nutritional status estimation, environmental effects and anthropometric parameters worth much concerns from scientists, so we came to study the essential dental indices, and major physical and biochemical properties in different body fluids of DS patients. 3- No paper has mentioned yet the possible elements that DS needs in food. 4- Most doctors do not really consider that trisomy 21 alters the overall metabolism and both the physical and biochemical properties of the biological fluids, enough to account for differences in DS pertaining food and the psychology of the patients. 5- Knowledge integration between saliva and oral pathology is far from being complete. Therefore, it is of critical importance to establish which salivation patterns and concentration ranges of each salivary component are to be considered as normal in order for the clinician to diagnose altered salivary phenotypes possibly linked to pathological systemic or oral conditions. 6- In an almost unlimited number of pathologic conditions, there is no study yet has studied the allowable minerals concentrations and the impact effects of heavy metals on the brain. For instance, we do not know yet, how these elements can affect the biochemical pathways? Or which can enhance the neurotransmitter system? We think heavy metals are triggered by environmental factors, pathological condition, or alterations in genotype. To date, environmental factors have not received the research attention that they warrant in medical treatment. 7- Recently, researchers had proposed the possibility of using saliva as an alternative to blood in diagnosing and monitoring of diseases. 8- It is currently essential to study whether the salivary indices, physical and biochemical characteristics would be altered in DS even little is known about dental issues and the periodontal diseases caused by poor oral hygiene in DS. 9- Reports on the chemical metabolism in disabilities are scarce. 10- No biomarkers have been established for minerals (as manganese) exposures. 11- No paper has linked before the health of disabilities to the nutrition and environment. The current study will provide highly influential impacts on Down's syndrome (DS) patient's life and biomedical science. For instance, it enhances our understanding of the salivary function in promoting healthy oral condition associated with DS patients. DS's anomalies (i.e. dental caries and cariogenesis) and their birth's distributions among single births and twins and their relations to mother's age were all defined. The registered participants (N) were 225, have been assessed for eligibility. The total exclusion states were 80, among them, 48 did not meet the inclusion criteria, 22 were declined to participate, and 10 were excluded for other reasons. 145 non-randomised states were assessed and then collaborated in this study. 74 healthy and non-diabetic young individuals and 71 DS children received allocated to intervention with no discounted interventions or any lost to follow-up criterion. Salivary buffering capacity of the controls (N =10× 5 repetitions) and Down's syndrome (N =10× 5 repetitions) were measured. Periodontal, biochemical saliva, and elemental analyses in other biological samples were 145×3, 145×5, and 145×5, respectively. Health-related quality of life (HRQoL) was registered in 71 DS parents. HRQoL in parents of DS children (6-15 years, 50×3) was assessed and tabulated. 71 DS patients prescribed different therapies for feeding difficulties and their Standard of Living was further assessed. Basic physiology and biochemistry were analysed in controls (23×3) and DS patients (23×3). However, due to a shrink available data related to the scope of this study, we compared only some data with previous studies and added proper justifications for new observations. In specific, launching from our observations, the oral prophylaxis, dental hygiene recommendations, and medical treatments were all described in more and sufficient details which can extremely avail both DS patients and doctors. Stakeholders: Clinical biochemists, biologists researching in the medical aspects of genetic disorders and birth defects, analytical chemists, biological chemists, oral biologists, developmental biologists, dieticians, global health organisations, nutritionists, ecologists, human and medical geneticists, paediatricians, pathologists, physiologists, neuroscientists, gynaecologists, psychologists, dentists, researchers and students in life sciences, researchers in biofluids, specialists in biochemical genetics and clinical genetics, anthropologists and researchers in hygiene and communicable diseases, and Down's syndrome' relatives and caregivers.

Brief summary in scientific language

Down's syndrome children between their nature and toxic attractions from the environment, oral conservative and prosthetic treatment with Duraphat as an alternative medicine to classic topical fluoride