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| Name | Class |
|---|---|
| Mahidol University | OTHER |
| Srinakharinwirot University | OTHER |
| Ministry of Health, Thailand | OTHER_GOV |
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This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Moisturizing Jelly | Experimental | Daily intake of oral moisturizing jelly 5 times/day for two months |
|
| Artificial saliva | Active Comparator | Daily use of non-edible oral lubricating gel 5 times/day for two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral moisturizing jelly | Dietary Supplement | Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in subjective dry mouth score compared to baseline | Evaluation of subjective dry mouth score by questionaire | Baseline, 1 and 2 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in objective dry mouth score compared to baseline | Evaluation of objective dry mouth score by oral examination | Baseline, 1 and 2 months after intervention |
| Changes in salivary pH compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aroonwan Lam-ubol, DDS, PhD | Srinakarinwirot University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonburi Cancer Hospital | Chon Buri | Changwat Chon Buri | 20000 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32779011 | Derived | Lam-Ubol A, Matangkasombut O, Trachootham D, Tarapan S, Sattabanasuk V, Talungchit S, Paemuang W, Phonyiam T, Chokchaitam O, Mungkung OO. Efficacy of gel-based artificial saliva on Candida colonization and saliva properties in xerostomic post-radiotherapy head and neck cancer patients: a randomized controlled trial. Clin Oral Investig. 2021 Apr;25(4):1815-1827. doi: 10.1007/s00784-020-03484-1. Epub 2020 Aug 10. | |
| 31732852 |
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| Artificial saliva | Other | A non-edible oral lubricating gel for dry mouth patients |
|
|
Evaluation of salivary pH using pH indicator paper
| Baseline, 1 and 2 months after intervention |
| Changes in salivary buffering capacity compared to baseline | Evaluation of salivary buffering capacity using a commercial saliva check buffer kit | Baseline, 1 and 2 months after intervention |
| Changes in Candidal counts of saliva compared to baseline | Evaluation of number of fungal colonies of Candida spp. in saliva by culture | Baseline, 1 and 2 months after intervention |
| Changes in energy intake compared to baseline | Evaluation of energy intake per day using dietary record and analysis | Baseline, 1 and 2 months after intervention |
| Changes in subjective swallow ability compared to baseline | Evaluation of subjective swallow ability using EAT-10 questionaire | Baseline, 1 and 2 months after intervention |
| Changes in appetite compared to baseline | Evaluation of appetite using questionnaire | Baseline, 1 and 2 months after intervention |
| Changes in tolerance to spicy food | Evaluation of tolerance to spicy food using questionnaire | Baseline, 1 and 2 months after intervention |
| Changes in umami taste recognition threshold compared to baseline | Evaluation of umami taste recognition threshold using filter paper disc method | Baseline, 1 and 2 months after intervention |
| Derived |
| Nuchit S, Lam-Ubol A, Paemuang W, Talungchit S, Chokchaitam O, Mungkung OO, Pongcharoen T, Trachootham D. Alleviation of dry mouth by saliva substitutes improved swallowing ability and clinical nutritional status of post-radiotherapy head and neck cancer patients: a randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2817-2828. doi: 10.1007/s00520-019-05132-1. Epub 2019 Nov 15. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012464 | Saliva, Artificial |
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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