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NCT Number: NCT04252209

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

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.

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Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Cairo Univeristy

Cairo, 020, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

natural herbs of coconut, aloe vera, and pepperint

Other

mixture of herbal oils of coconut, peppermint, aloe vera

Other names: natural products

carboxy methyl cellulose

Other

a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Other names: CMC

Primary outcomes

  1. subjective oral dryness

    Time frame: 14 days

    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

Secondary outcomes

  1. objective oral dryness

    Time frame: 14 days

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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