MedDRA - DOWN SYNDROME
Conditions
Interventions
Group 1: 71 DS (trisomy of chromosome 21 (21q22)) children received allocated to intervention with no discounted interventions or any lost to follow-up criterion. The procedure adopted in this work co
Sponsors
Department of Basic Sciences, Faculty of Dental Medicine, Damascus University, Main Highway, AlMazaa, Damascus, Syria
Eligibility
Sex/Gender
Male
Age
2 Years to 15 Years
Inclusion criteria
Inclusion criteria: Males, children, Permanent residences in Damascus, Living far from plaster dust sources of any possible adjacent construction sites and far from the industrial zone (incl. concrete plants), Non-smokers (all kinds of tobacco), Non-smoker families, Unstimulated saliva samples, Controls were healthy and non-diabetic young individuals, Controls had no systemic diseases or any local infection before 3 months and did not also take any medication for at least 3 months before sample collection, DS children patients were trisomy 21 diagnosed by karyotype test and assessed by clinical examination. Patients were euthyroid at the time of study as their thyroid-stimulating hormone (TSH) and free thyroxine hormone (FT4) were within the normal range.
Exclusion criteria
Exclusion criteria: Females, Male smokers, Smoker families, Systemic diseases, Participant takes medication for at least 3 months, Children with congenital oligodontia and delayed eruption (more than 1yr), Individuals with the history of antibiotics, anticholinergic, antihistaminic and antipsychotic therapy two weeks prior to sample collection, intervened medications that could get in the way with ions metabolisms such as taking vitamin D, aspirin, or herbal medicine which can easily interfere for instance with Fe metabolism. In addition, candidates with concentrations of thiocyanate higher than 80 mg SCN-/L (1 mg SCN-/L =17.2 µM SCN-/L) saliva or 3.00 mg SCN-/L serum were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Biochemical change in saliva (control and DS patients) Primary timepoint : 30 days post commencement of intervention and each individual gave at least 40 mL of saliva in consecution during 14-55 days. The volume of parotid saliva and whole saliva were collected in as few collecting sessions as compatible with the rate of salivary flow rate (SFR) and subject co-operation, 30 min was the maximum time allocated for any one meeting. Notably, parotid saliva was obtained from the subjects (DS and controls) using a modified Carlson-Crittenden device. In general, saliva was collected under petroleum ether (A.R.) (Sigma-Aldrich Chemie Gmbh, Munich, Germany) and these samples were collected in Salivette tubes (Sarstedt AG & Co., Nümbrecht, Oberbergischer Kreis, Germany) after overnight fasting. The chemical analyses were included the following: pH, electrical conductivity (EC), total dissolved solids (TDS), total suspended solids (TSS), salinity, turbidity, colour, saliva flow rate (SFR), the decay, missing, and filled tooth (DMFT) index, glucose, total protein, carbon dioxide (CO2), total phosphorus (TP), total nitrogen (TN), major alkaline and alkaline-earth ions, aluminium (Al), silicon (Si), and heavy metals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: The oral health assessment (DS children) followed the protocol used in the National Oral Health Survey which was based on World Health Organization (WHO) guidelines Secondary timepoint : The behavioural self-administered questionnaire was carried out 7 days post commencement of intervention for each individual and an oral health assessment (examination covered oral mucosal pathology, malocclusion, periodontal disease, dental caries and treatment needs) was executed by a single dental surgeon with experience in the dental examination of people with disability development (DD) 18 days post commencement of intervention. Secondary outcome [1]: Dissolved CO2 in saliva using the micro-diffusion method of Conway. Secondary timepoint [1]: The first day of sample collection and during 17-55 days post commencement of intervention. Secondary outcome [2]: IgA determination in saliva using Stone method Secondary timepoint [2]: The first day of sample collection and during 17-55 days post commencement of intervention. Secondary outcome [3]: Total nitrogen of saliva determined by the micro-Kjeldahl method. Secondary timepoint [3]: The first day of sample collection and during 17-55 days post commencement of intervention. Secondary outcome [4]: The physical characterisation of saliva: Ash weight measured by ASTM E1755-01 method, Saliva flow rate (SFR) measured by graduated syringes method, Viscosity measured by Ostwald-type capillary viscometer, Surface tension measured by Micro capillary rise apparatus, Electrical conductivity measured by ASTM D1125 method using MP-4 Portable Meter, Salinity measured by MP-4 Portable Meter, Total dissolved solids (TDS) measured by MP-4 Portable Meter using ASTM D5, Total suspended solids measured by ASTM D5907 method using DR 1900, and Turbidity measured by ASTM D1889 using 2100Q IS Secondary timepoint [4]: The first day of sample collection and during 17-55 days post commencement of intervention. Secondary outcome [5]: Total | — |
Countries
Syria
Contacts
Public ContactMazen Aljurf
CosmeSurge Clinics, Bawsher State, Muscat, Sultanate of Oman, P.O. Box 1822, P.C. 130
Outcome results
None listed