Clinical trial NCT02317172: Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
Official title: Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Hypertension
Diabetes Mellitus
Keywords: Saliva substitute
Edible gel
Xerostomia
Diabetes Mellitus
Hypertension
Lead sponsor: Dental Innovation Foundation Under Royal Patronage
Sponsor class: OTHER
Collaborators: name: Thammasat University
name: Srinakharinwirot University
name: Mahidol University
name: Ministry of Health, Thailand
First posted: 2014-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.

Detailed description: A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.

Eligibility criteria: Inclusion Criteria:

* Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
* Report symptoms of dry mouth

Exclusion Criteria:

* Subjects with uncontrolled systemic diseases
* Subjects who aspirate upon eating
* Subjects who smoke
* Subjects who are allergic to component of the intervention

Primary outcomes:
measure: Changes in subjective dry mouth score
timeFrame: baseline, 2 weeks and 4 weeks after intervention
Secondary outcomes:
measure: Changes in objective dry mouth score
timeFrame: baseline, 2 weeks and 4 weeks after intervention
measure: Changes in salivary Potential of Hydrogen ion (pH)
timeFrame: baseline, 2 weeks and 4 weeks after intervention
measure: Changes in salivary buffering capacity
timeFrame: baseline, 2 weeks and 4 weeks after intervention
measure: Satisfaction of the edible gel-based artificial saliva
timeFrame: at the first day of trial
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Department of Health, Ministry of Health
Study officials:
affiliation: Srinakharinwirot University
name: Aroonwan Lam-ubol, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.