Oral dryness is a common problem with serious consquences, especially among elderly individuals. The most common reason for oral dryness is drug consumption. Research has shown that an individual with more than 5 prescribed drug is at risk for oral problems. Drug consumtion is increasing among elderly, mostly due to lack in cooperation in the health care system. Oral dryness have impact on quality of life with eating difficulties and an increased rsik for dental caries.
Conditions
Interventions
Product Name: Xerodent
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Malic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28,6-per tablet
IN
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Swedish talking patients at least 65 years old with at least 6 medically prescribed drugs (not products free for sale) and with at least 10 natural teeth. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sjögrens syndrom, radiation teraphy against head/neck cancer, ongoing treatment with cytostatics, serious diseases that may undo fulfillment of participation in the study, communication difficulties in swedish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To objectively and subjectively evaluate the effect of 6 months treatment with Xerodent in elderly patients with at least 6 medically prescribed drugs. This is mainly measured by a subjectively valued guestion in a formula with VAS-scales, "How dry is your mouth?";Secondary Objective: The study uses several instruments to evaluate the effect. The objectives are : Objectively valued items in an oral health assessment by nursing staff, questions in two subjectively valued formulas by the study participants, amounts of mutans streptococci and lactobacillus in saliva, amount of unstimulated and stimulated saliva and consumtion of the prescribed study drugs. The study also develop the cooperation between general and dental health around the elderly patients oral health to decrease personal suffering and give society financial advantages. ;Primary end point(s): Oral health is judged by an oral assessment intrument, modified for swedish circumstances. The instrument has a scale from 1-3 in each item where degree 2-3 leads to a recommended activity. The nursing staff will have education in oral health and instruction in the use of the assessment instrument by a registered nurse with a master degree in the area of oral health and long experience of oral health education for nursing staff. The patient judge his/her own oral health with OHIP 14 and VAS scales. OHIP 14 gives a picture of what problems the patient is suffering from most and the VAS-scales give information about in which direction the problems have changed during the study time. Salivary flow is performed by collecting a)unstimulated saliva during 15 minutes and b) stimulated saliva during 5 minutes after having chewed on a bit of paraffin. The amount of saliva is measured by weight. Education in saliva measurement is given to the nursing staff by the project leader (Inger Wårdh). The stimulated saliva is also used as material for a microbial analysis and is sent to a laboratory for analysis o | — |
Countries
Sweden
Outcome results
None listed