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At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures:
General measures ; review and control of drugs,hydration and dietary advice:
The main recommendations are found in the following scheme.
Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion.
Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline
Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.
Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP EXPERIMENTAL | Experimental | Gel xerostomia Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
|
| CONTROL GROUP | Placebo Comparator | Gel placebo Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gel xerostomia | Drug | Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
|
| Measure | Description | Time Frame |
|---|---|---|
| OHIP 14 | Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases | 1moth |
| Sialometry | Drenaje | 1moth |
| Test Thonsom xerostomy | Xerostomia Inventory. the higher the outcome, quality of life decreases | 1moth |
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Inclusion Criteria:
Exclusion criteria
The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pia López-Jornet, PhD | Contact | 639473308 | majornet@um.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lopez-Jornet Pia | Recruiting | Murcia | N/A = Not Applicable | 30008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30923424 | Background | Assery MKA. Efficacy of Artificial Salivary Substitutes in Treatment of Xerostomia: A Systematic Review. J Pharm Bioallied Sci. 2019 Feb;11(Suppl 1):S1-S12. doi: 10.4103/jpbs.JPBS_220_18. | |
| 27031061 | Background | Gil-Montoya JA, Silvestre FJ, Barrios R, Silvestre-Rangil J. Treatment of xerostomia and hyposalivation in the elderly: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e355-66. doi: 10.4317/medoral.20969. |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D054327 | Lubricants |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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|
| gel placebo | Other | Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night |
|
| Lopez-Jornet Pia | Not yet recruiting | Murcia | N/A = Not Applicable | 30008 | Spain |
|
| 31261876 | Background | Lysik D, Niemirowicz-Laskowska K, Bucki R, Tokajuk G, Mystkowska J. Artificial Saliva: Challenges and Future Perspectives for the Treatment of Xerostomia. Int J Mol Sci. 2019 Jun 29;20(13):3199. doi: 10.3390/ijms20133199. |