An interventional study of Chamomile and Saline mouthwash in Xerostomia Due to Hyposecretion of Salivary Gland, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Background and Objectives: Chronic hemodialysis causes changes in blood chemistry as well as dry mouth, due to removal of excess fluids. Dry mouth is due to hyposalivation or change in saliva composition. Many herbal medicines have been used as treatment options. Since the chamomile was suggested as a potent oral moisturizer by previous studies that have been done in this field. Therefore, the investigators decided to assess the effect of chamomile oral rinse on the SXI score, salivary nitric oxide level, salivary flow rate, OHIP-14, serum creatinine and blood urea levels in elderly patients on chronic hemodialysis.
Material and Methods: It is an interventional randomized controlled clinical trial with a biochemical assessment. A chamomile, and placebo mouthwashes were provided to eighty-eight elderly participants with end-stage renal disease suffering from xerostomia. Patients were divided into 2 equal groups who used either the chamomile or placebo mouthwash for one month. The SXI score and salivary flow rate were evaluated for both groups at different intervals (baseline, 1 week, and 1 month). While salivary NO levels, OHIP-14, serum creatinine and blood urea levels evaluated at baseline and after one month only.
A double-blind (interventional) cross-sectional clinical trial was performed on 88 participants in the hemodialysis center at Benha university. The inclusion criteria were both genders above 30 years of age with ESRD and complaints of dry mouth sensation. The exclusion criteria were significant salivary gland damage (for example, due to anticancer medication), radiotherapy or chemotherapy history, and allergies).
Bottles containing chamomile mouthwash or the placebo (A or B) were tagged by a reliable person outside the research group and placed inside an opaque envelope along with the questionnaires. Each patient received two envelopes containing a bottle (A \& B) and a questionnaire. The results were analyzed exclusively by a statistics consultant at the end of the research. The patients were asked to express their sensation of dry mouth using subjective dry mouth score.
The Summated Xerostomia Inventory (SXI) (Thomson et al., 2011; Frigaard et al., 2023):
ESRD patients who met the eligibility criteria were asked about their subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements all recorded at 3 different intervals (at baseline- after 2 weeks- after 1 month).
Salivary flow rate: Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection was timed, so that flow rate (mL/min) could be measured.
The Oral Health Impact Profile (OHIP-14) utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often) that was evaluated after one month in both groups. A lower score in any of the five categories indicates higher satisfaction (Al-Zubeidi et al., 2012).
Serum creatinine and blood urea levels were assessed at baseline and after one month in both groups.
Nitric oxide levels were determined by Nitric Oxide Assay Kit (Colorimetric) using Griess reaction: The Bio Diagnostic Nitrite Assay Kit provides an accurate and convenient method for measurement of endogenous nitrite concentration as an indicator of nitric oxide production in biological fluids. It depends on the addition of Griess Reagents which convert nitrite into a deep purple azo compound, photometric measurement of the absorbance due to this azo chromophore accurately determines NO2 - concentration.
264 studies on the registry are indexed under Xerostomia; 48 are open to participants now.
This study's enrollment of 88 is above the median of 42 across 223 interventional studies indexed under Xerostomia.
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Both genders, aged above 65 years.
Exclusion Criteria:
* Chamomile was topically applied to the oral mucosa as oral rinse. * Based on this protocol, patients were had oral rinses 3 times per day. * Patients were instructed to perform chamomile rinses in the oral mucosa. * Patients were instructed not to swallow the chamomile oral rinse.
Other: Chamomile
Patients in the control arm followed the same protocol with normal saline rinses. As stated before, that use of 4% hypertonic saline solution mouthwash by elderly provided better oral health by decreasing xerostomia, oral tongue plaque, halitosis, and the number of oral bacteria. So the patients in the control group were benefited from the saline oral rinse.
Other: Saline mouthwash
* Chamomile was topically applied to the oral mucosa as oral rinse. * Based on this protocol, patients had oral rinses 3 times per day. * Patients were instructed to perform chamomile rinses in the oral mucosa. * Patients were instructed not to swallow the chamomile oral rinse.
Saline mouthwash was used by elderly patients in the control arm.
The Summated Xerostomia Inventory (SXI)
subjective severity of xerostomia using SXI score where the patient evaluates the frequency of complaints regarding five statements. Each statement has three possible replies: never, occasionally, or often, with scoring 1, 2, and 3, respectively. The SXI has a score range from (5 to 15), where a maximum score indicates severe problems related to dry mouth
Time frame: one month
Increase in unstimulated Salivary Flow Rate (ml/min)
Unstimulated whole saliva was collected for 5 min by spitting method. The collection was timed, so that flow rate (mL/min) could be measured. The normal unstimulated salivary flow rate is approximately 0.3-0.4 mL/min. A diagnosis of hyposalivation is made when the unstimulated salivary flow rate is ≤0.1 mL/min. Time Frame: baseline, 2 weeks and 4 weeks after intervention \] The outcome measure will be measured before and 2 and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week)
Time frame: one month
Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method
Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method \[ Time Frame: baseline and 4 weeks after intervention\] The outcome measure will be measured before and 4 weeks after continuous usage of chamomile mouth rinse (for at least 5 days per week).
Time frame: one month
The Oral Health Impact Profile (OHIP-14) questionnaire
(OHIP-14) utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often) that was evaluated after one month in both groups. A lower score in any of the five categories indicates higher satisfaction
Time frame: one month
Serum creatinine and blood urea levels
Kidney clinical parameters to evaluate the renal function, higher values are the worst, and lower values are the best.
Time frame: one month
Plan to share: No — will not share my raw data
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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