Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201923
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-01
Brief Title:
The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia A Randomized Controlled Clinical Trial With a Biochemical Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to evaluate the clinical efficacy of thyme honey as a mouth rinse in the management of polypharmacy-induced xerostomia concerning the unstimulated whole salivary flow rate and quality of life of patients along with a biochemical assessment of salivary nitric oxide levels
Detailed Description:
Saliva is a vital component in the mouth and the preservation of humans general health depends on good oral health Saliva contains primarily water 995 followed by a 03 mixture of inorganic salts enzymes and proteins There are many functions of saliva such as lubrication microbial homeostasis tooth protection digestion process taste buffering mineralization and wound healing So when the salivary flow or composition changes due to various causes these functions will be lost The normal unstimulated salivary flow rate is about 03-04 mlmin whereas the stimulated rate is 15-20 ml min When there is an objective hyposalivation 01- 02 mlmin unstimulated or 05 - 07 mlmin stimulated patients frequently complain of xerostomia Xerostomia can be defined as a subjective feeling of oral dryness that might be associated with a real decline in the salivary flow It can be considered a major problem that greatly affects a persons quality of life due to dysphagia occurrence and taste sensation impairment The prevalence of xerostomia in the general population ranged from 09 to 46 So it constitutes a serious health issue requiring attention The causes of xerostomia can be categorized as systemic or local depending on their nature Furthermore xerostomia is classified as permanent or periodic based on how long the symptoms last Systemic causes of xerostomia included endocrinological eg diabetes mellitus autoimmune thyroid diseases autoimmune eg Sjogrens syndrome rheumatoid arthritis systemic lupus erythematosus infectious eg hepatitis C virus and granulomatous eg tuberculosis and sarcoidosis diseases while Local factors of xerostomia comprised multiple medications polypharmacy radical radiotherapy for the treatment of head and neck malignancies and lifestyle factors such as alcohol tobacco and caffeine consumption Recently it was also documented that 459 of patients with confirmed SARS-CoV-2 infection experienced xerostomia with a considerable majority 765 of them noting that it was their first time experiencing xerostomia Polypharmacy is thought to be the most common cause of xerostomia Several definitions of polypharmacy were reported in the literature There was a wide range of numerical-only definitions of polypharmacy ranging from two or more medications to 11 or more medications Also the numerical definitions of polypharmacy incorporating duration of therapy ranged from the use of two or more medications for more than 240 days long-term use to five to nine medications used for 90 days or more While descriptive definitions explained co-prescribing multiple medications and simultaneous and long-term use of different drugs by the same individual More than 400 drugs have an impact on the function of the salivary glands and promote the development of xerostomia Drugs that frequently contribute to xerostomia include antiparkinsonian pharmaceuticals antipsychotics antidepressants anticholinergic antihistamines tranquilizers oral hypoglycemics diuretics opioids cytotoxic agents and antihypertensive medications The precise processes by which some drugs produce xerostomia arent yet understood
Various treatment modalities can be used to treat xerostomia and salivary hypofunction depending on the underlying cause of the condition which are classified into systemic and topical agents The FDA has approved systemic sialogogues namely pilocarpine and cevimeline as a treatment modality Cevimeline and the other medications are parasympathomimetics and act on muscarinic receptors Despite their powerful effect severe highly prevalent side effects are caused after their regular administration including vasodilatation emesis excessive sweating hypotension bronchoconstriction increased urinary frequency bradycardia and vision problems Topical and local medications for xerostomia continue to be a more appealing and secure therapy choice These include sugar-free chewing gums salivary stimulants and substitutes salivary substitutes make an effort to resemble natural saliva and act as oral lubricants without changing the salivary flow rate and due to their viscosity they are not commonly used and not accepted by most patients These substitutes are mainly utilized when completely damaged salivary glands Topical salivary stimulants are the most popular and widely tolerated among patients mainly used when there is residual functional salivary tissue These topical stimulants can be divided into acid or mechanically-driven Mechanical salivary stimulation occurs through the utilization of sugar-free chewing gums which aim to stimulate the major salivary glands to increase the salivary flow While acid-driven stimulation occurs through acidification of the oral cavity with malic acid and citric acid to increase the salivary flow rate One of the topical salivary stimulants that have been recently studied is the thyme honey mouth rinse Thyme honey is used for xerostomia under the assumption that it has saliva-stimulating effects as it consists of various organic acids such as ascorbic acid citric acid and malic acid which are used as saliva stimulators Previous research has demonstrated that organic acids stimulate the chemoreceptors in the oral cavity increasing the flow of saliva Later thyme honey has proven its efficacy in preventing radiation-induced salivary gland destruction and xerostomia Thyme honey has antibacterial antiviral antifungal anti-inflammatory antioxidant and anticarcinogenic properties It has been used to treat burns surgical wounds and oral infections due to its antibacterial and analgesic properties and ability to promote epithelialization The majority of honey varieties produce hydrogen peroxide when diluted due to the activation of the enzyme glucose oxidase which oxidizes glucose to gluconic acid and hydrogen peroxide The main component of honeys antibacterial activity is hydrogen peroxide as well as the presence of phytochemicals and its acidic environment with a pH ranging from 32 to 45
Nitric oxide in the saliva is produced by the nerve ending in the salivary glands endothelium and macrophages in response to the oral bacteria Nitric oxide levels rise and oxidative stress occurs as a result of phagocyte induction So High levels of nitrate and nitrite the stable end products of nitric oxide in typical saliva help to locally produce nitrogen intermediates with possible antibacterial capabilities enhanced mucosal blood flow and improved oral mucus formation The salivary NO level in patients with xerostomia is significantly lower than in those without xerostomia So salivary nitric oxide level could be considered a predictor of xerostomia
A Clinical Assessment all patients are evaluated at baseline 2 and 4 weeks after intervention through
1 Measurement of Unstimulated Salivary Flow Rate UFR by spitting method for assessment of salivary gland hypofunction Measurements are expressed in millimeters per minute mlmin If the unstimulated flow rate is less than 02 mLmin it will be considered to represent salivary gland hypofunction and this patient will be included in the study
2 Measurement of subjective symptoms of oral dryness by using a questionnaire consisting of four questions that assess the severity of dry mouth patients will answer these questions with yes or no positive response to any question indicates a reduced unstimulated salivary flow rate and this patient will be included in the study
Q1 Does it seem like there isnt enough saliva in your mouth Q2 Do you ever have trouble swallowing Q3 Does eating a meal cause your mouth to feel dry Q4 Do you drink liquids to make it easier to swallow dry food
3 Measurement of objective signs of oral dryness by using a clinical oral dryness score CODS consisting of a 10-point scale each point representing a feature of dryness in the mouth The clinician scores the features observed in the patients mouth from 0-10 Patients with a score less than 2 will be excluded
1 The buccal mucosa becomes stuck with the mirror 2 The tongue adheres to the mirror 3 Saliva with foam 4 There isnt any saliva collecting on the mouths floor 5 The papillae of the tongue have disappeared 6 Modified or smooth gingival structure 7 The mucosa of the mouth particularly the palate appears glassy 8 Lobular or fissured tongue 9 Cervical caries that have just been repaired within the past six months more than two teeth 10 Debris on the palate excluding under dentures
All patients are also evaluated at baseline and after one month from intervention through the following
4 Xerostomia-related quality of life questionnaire includes 15 questions regarding how dry mouth affects a persons quality of life The questions are
1 Is the type or quantity of food you can eat restricted by your mouth dryness 2 Does having a dry mouth make you uncomfortable 3 Does your oral dryness make you anxious or concerned a lot 4 Do you avoid social situations because of dry mouth 5 Is it unsettling to eat in front of others when your mouth is dry 6 When speaking in front of other people does your dry mouth make you feel uneasy 7 Does your oral dryness make you nervous 8 Are you worried about how your teeth and mouth seem because of your mouth dryness 9 Do you find it difficult to enjoy life because of your dry mouth 10 Does having a dry mouth affect your everyday activities 11 Does your mouth dryness affect the intimacy with your relationships 12 Does dry mouth affect how well you can taste food 13 Does having a dry mouth lessen your overall enjoyment of life 14 Does your mouth dryness interfere with every part of your life 15 How would you feel if you were forced to live the remainder of your days with a dry mouth the way it is right now The questionnaire will be translated verbally and answers will be collected orally from the patients and documented by an investigator not involved in assigning the intervention to patients
B Biochemical Assessment
Measurement of salivary nitric oxide NO level measured at baseline and after one month in the Lab
Statistical Methods
All the data will be collected and analyzed statistically Categorical data will be represented as frequency n and percentage and will be analyzed using the chi-square test Numerical data will be explored for normality by checking the data distribution calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests If the data was found to be normally distributed it will be presented as mean and standard deviation values and an independent t-test will be used for the analysis If the assumption of normality is found to be violated the data will be presented as median and range values and will be analyzed using the Mann-Whitney U test The significance level will be set at p 005 for all tests Statistical analysis will be performed with IBM SPSS Statistics Version 26 for Windows
Various treatment modalities can be used to treat xerostomia and salivary hypofunction depending on the underlying cause of the condition which are classified into systemic and topical agents The FDA has approved systemic sialogogues namely pilocarpine and cevimeline as a treatment modality Cevimeline and the other medications are parasympathomimetics and act on muscarinic receptors Despite their powerful effect severe highly prevalent side effects are caused after their regular administration including vasodilatation emesis excessive sweating hypotension bronchoconstriction increased urinary frequency bradycardia and vision problems Topical and local medications for xerostomia continue to be a more appealing and secure therapy choice These include sugar-free chewing gums salivary stimulants and substitutes salivary substitutes make an effort to resemble natural saliva and act as oral lubricants without changing the salivary flow rate and due to their viscosity they are not commonly used and not accepted by most patients These substitutes are mainly utilized when completely damaged salivary glands Topical salivary stimulants are the most popular and widely tolerated among patients mainly used when there is residual functional salivary tissue These topical stimulants can be divided into acid or mechanically-driven Mechanical salivary stimulation occurs through the utilization of sugar-free chewing gums which aim to stimulate the major salivary glands to increase the salivary flow While acid-driven stimulation occurs through acidification of the oral cavity with malic acid and citric acid to increase the salivary flow rate One of the topical salivary stimulants that have been recently studied is the thyme honey mouth rinse Thyme honey is used for xerostomia under the assumption that it has saliva-stimulating effects as it consists of various organic acids such as ascorbic acid citric acid and malic acid which are used as saliva stimulators Previous research has demonstrated that organic acids stimulate the chemoreceptors in the oral cavity increasing the flow of saliva Later thyme honey has proven its efficacy in preventing radiation-induced salivary gland destruction and xerostomia Thyme honey has antibacterial antiviral antifungal anti-inflammatory antioxidant and anticarcinogenic properties It has been used to treat burns surgical wounds and oral infections due to its antibacterial and analgesic properties and ability to promote epithelialization The majority of honey varieties produce hydrogen peroxide when diluted due to the activation of the enzyme glucose oxidase which oxidizes glucose to gluconic acid and hydrogen peroxide The main component of honeys antibacterial activity is hydrogen peroxide as well as the presence of phytochemicals and its acidic environment with a pH ranging from 32 to 45
Nitric oxide in the saliva is produced by the nerve ending in the salivary glands endothelium and macrophages in response to the oral bacteria Nitric oxide levels rise and oxidative stress occurs as a result of phagocyte induction So High levels of nitrate and nitrite the stable end products of nitric oxide in typical saliva help to locally produce nitrogen intermediates with possible antibacterial capabilities enhanced mucosal blood flow and improved oral mucus formation The salivary NO level in patients with xerostomia is significantly lower than in those without xerostomia So salivary nitric oxide level could be considered a predictor of xerostomia
A Clinical Assessment all patients are evaluated at baseline 2 and 4 weeks after intervention through
1 Measurement of Unstimulated Salivary Flow Rate UFR by spitting method for assessment of salivary gland hypofunction Measurements are expressed in millimeters per minute mlmin If the unstimulated flow rate is less than 02 mLmin it will be considered to represent salivary gland hypofunction and this patient will be included in the study
2 Measurement of subjective symptoms of oral dryness by using a questionnaire consisting of four questions that assess the severity of dry mouth patients will answer these questions with yes or no positive response to any question indicates a reduced unstimulated salivary flow rate and this patient will be included in the study
Q1 Does it seem like there isnt enough saliva in your mouth Q2 Do you ever have trouble swallowing Q3 Does eating a meal cause your mouth to feel dry Q4 Do you drink liquids to make it easier to swallow dry food
3 Measurement of objective signs of oral dryness by using a clinical oral dryness score CODS consisting of a 10-point scale each point representing a feature of dryness in the mouth The clinician scores the features observed in the patients mouth from 0-10 Patients with a score less than 2 will be excluded
1 The buccal mucosa becomes stuck with the mirror 2 The tongue adheres to the mirror 3 Saliva with foam 4 There isnt any saliva collecting on the mouths floor 5 The papillae of the tongue have disappeared 6 Modified or smooth gingival structure 7 The mucosa of the mouth particularly the palate appears glassy 8 Lobular or fissured tongue 9 Cervical caries that have just been repaired within the past six months more than two teeth 10 Debris on the palate excluding under dentures
All patients are also evaluated at baseline and after one month from intervention through the following
4 Xerostomia-related quality of life questionnaire includes 15 questions regarding how dry mouth affects a persons quality of life The questions are
1 Is the type or quantity of food you can eat restricted by your mouth dryness 2 Does having a dry mouth make you uncomfortable 3 Does your oral dryness make you anxious or concerned a lot 4 Do you avoid social situations because of dry mouth 5 Is it unsettling to eat in front of others when your mouth is dry 6 When speaking in front of other people does your dry mouth make you feel uneasy 7 Does your oral dryness make you nervous 8 Are you worried about how your teeth and mouth seem because of your mouth dryness 9 Do you find it difficult to enjoy life because of your dry mouth 10 Does having a dry mouth affect your everyday activities 11 Does your mouth dryness affect the intimacy with your relationships 12 Does dry mouth affect how well you can taste food 13 Does having a dry mouth lessen your overall enjoyment of life 14 Does your mouth dryness interfere with every part of your life 15 How would you feel if you were forced to live the remainder of your days with a dry mouth the way it is right now The questionnaire will be translated verbally and answers will be collected orally from the patients and documented by an investigator not involved in assigning the intervention to patients
B Biochemical Assessment
Measurement of salivary nitric oxide NO level measured at baseline and after one month in the Lab
Statistical Methods
All the data will be collected and analyzed statistically Categorical data will be represented as frequency n and percentage and will be analyzed using the chi-square test Numerical data will be explored for normality by checking the data distribution calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests If the data was found to be normally distributed it will be presented as mean and standard deviation values and an independent t-test will be used for the analysis If the assumption of normality is found to be violated the data will be presented as median and range values and will be analyzed using the Mann-Whitney U test The significance level will be set at p 005 for all tests Statistical analysis will be performed with IBM SPSS Statistics Version 26 for Windows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None