the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia

Study Overview
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Brief Summary
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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
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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 The medication will be withdrawn if any allergic reaction occurs.

Official Title
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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

Conditions
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Sjogren's Syndrome, Xerostomia

Intervention / Treatment
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* Other: natural herbs of coconut, aloe vera, and pepperint
* Other: carboxy methyl cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Patients physically able to participate in the clinical trial. Patients diagnosed with Sjogren's syndrome using 2016 ACR/EULAR classification criteria (Shiboski et al., 2017). Secondary sjogren patients with rheumatoid arthritis. Patients with clinical oral dryness positive scores. Exclusion Criteria: Patients with previous radiotherapy. Patients not approved to participate in the clinical trial. Patients didn't complain from xerostomia. Patients with diabetes mellitus. Patients taking drugs caused xerostomia as antidepressants, anticholinergics, antihistamines, and anxiolytics and antihypertensives (Campos et al., 2019). Patients with symptomatic oral lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with sjogren's received natural mixture<br>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%. applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep | Other: natural herbs of coconut, aloe vera, and pepperint<br>* mixture of herbal oils of coconut, peppermint, aloe vera<br>* Other names: natural products;|
| Active Comparator: patients with sjogren's recievrd CMC<br>the control is a moisturizing gel containing 3% peppermint essential oil, 3% carboxy methyl cellulose, 10% propylene glycol, and 0.1% potassium sorbate and water up to 100%. applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep | Other: carboxy methyl cellulose<br>* a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.<br>* Other names: CMC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective oral dryness | subjective oral dryness measured by bother 1 scale. It is patient centered scale as the patient reported how much he suffer from oral dryness on scale from 1 - 10.as 1 mean mild dryness and 10 mean severe oral dryness | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective oral dryness | using the Challacombe Scale. It will be assessed by the investigator in the first visit (baseline assessments before the interventions) and in the end of two weeks (final assessments).as score 1 mean mild oral dryness and score 10 mean severe oral dryness | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerostomia, oral dryness, dry mouth