Clinical trial NCT04252209: the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia
Official title: the Effect of Mixture of Natural Products As Salivary Substitute In Comparison To Carboxy Methyl Cellulose In Treatment Of Xerostomia In Patients With Sjogren's Syndrome: Cross Over Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sjogren's Syndrome
Xerostomia
Keywords: xerostomia
oral dryness
dry mouth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 50% of patients will start with intervention (A) for 2 weeks then wash out periods for 7 days then control for 2 weeks and the other 50% will start with control for 2 weeks then wash out periods for 7 days then intervention (B) for 2 weeks.
Primary purpose: TREATMENT

Brief summary: evaluate the efficacy of natural herbal mixture of aloe vera gel, coconut oil and peppermint in comparison to the carboxy methyl cellulose on xerostomia in a sample of patients with Sjogren's syndrome.

Detailed description: The study will be held in the Rheumatology clinic at El Kasr Al-Ainy Cairo University Hospital in patients with Sjogren's syndrome. Population: A random sample of adult patients diagnosed with primary or secondary Sjogren's syndrome attending at the Rheumatology clinic in El Kasr Al-Ainy, Cairo University Hospital will be enrolled in the study in a consecutive order.

The interventions will be in the form of gel to be maintained for long period in the oral cavity. The intervention is a moisturizing gel containing 10% aloe vera jelly, 10% coconut oil, 3% peppermint essential oil, 3% carboxy methyl cellulose, 10% propylene glycol, and 0.1% potassium sorbate and water up to 100%. The control is also a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Both gels had similar appearance, color, smell, and weight. They will be produced by professional pharmacist in faculty of pharmacy, Al Azher university, Cairo, Egypt.it was taken from previous study with modification in percentage of aloe vera and adding coconut oil. Both gels will be applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep . The same individuals will deliver the trial interventions in all study groups, both gels will be used for 2 weeks then washout period for 7 days then cross over them. Modification of life style will be promoted as daily tooth brushing, hydration with sufficient amounts of water, eating fibrous food as fruits and vegetables, avoid any alcohol mouth wash or any other topical oral products. The medication will be withdrawn if any allergic reaction occurs.

Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. Patients physically able to participate in the clinical trial.
3. Patients diagnosed with Sjogren's syndrome using 2016 ACR/EULAR classification criteria (Shiboski et al., 2017).
4. Secondary sjogren patients with rheumatoid arthritis.
5. Patients with clinical oral dryness positive scores.

Exclusion Criteria:

1. Patients with previous radiotherapy.
2. Patients not approved to participate in the clinical trial.
3. Patients didn't complain from xerostomia.
4. Patients with diabetes mellitus.
5. Patients taking drugs caused xerostomia as antidepressants, anticholinergics, antihistamines, and anxiolytics and antihypertensives (Campos et al., 2019).
6. Patients with symptomatic oral lesions

Primary outcomes:
measure: subjective oral dryness
timeFrame: 14 days
Secondary outcomes:
measure: objective oral dryness
timeFrame: 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo Univeristy
Study officials:
References:
citation: Atashi V, Yazdannik A, Mahjobipoor H, Ghafari S, Bekhradi R, Yousefi H. The Effects of Aloe vera-Peppermint (Veramin) Moisturizing Gel on Mouth Dryness and Oral Health among Patients Hospitalized in Intensive Care Units: A Triple-Blind Randomized Placebo-Controlled Trial. J Res Pharm Pract. 2018 Apr-Jun;7(2):104-110. doi: 10.4103/jrpp.JRPP_18_21.