The Efficacy of Using Escitalopram and Citalopram on Oral health: Including Stomatitis and Halitosis

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The Efficacy of Using Escitalopram and Citalopram on Oral health: Including Stomatitis and Halitosis

Description

A basic overview of the protocol. Explanation of major points in 8-10 slides. 

The Efficacy of Using Escitalopram and Citalopram on Oral health: Including Stomatitis and Halitosis

Introduction

Escitalopram and Citalopram, both used in mental health treatment, are selective serotonin reuptake inhibitors (SSRIs). They have sorbitol, de – ionized water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavoring as inactive components. Both Escitalopram and Citalopram, given orally, are effective treatments for major depressive disorder and generalized anxiety disorder.

Mental and physical disease have an effect on dental hygiene. Some issues with general health, mental or otherwise, have an immediate impact on oral hygiene, while others have more far-reaching and indirect consequences. Studies have proven that anxiety and depression are psychological diseases affecting oral health. Psychological disorders cause many oral health problems, such as oral inflammation and halitosis So, in this study, we will measure the efficacy of mental health medications on oral health for mental disorder patients.

 Study Rationale

Studies have proven a relationship between mental health disorders and gastrointestinal diseases  In addition, gastrointestinal diseases affect oral health. Therefore, we will test the efficacy of mental health medications on oral health.

We will have two groups of participants with mental disorders, who will identify using the Mental Health scale. Oral health will assess before and after the study through a personal questionnaire and oral health scale. Everyone will receive a standard of care. The first group will take the medication for 8-12 weeks, and the second group will take a placebo with the measure of care level.

Follow-up is done during this period to determine the extent of existing changes.

Background

Escitalopram and Citalopram are drugs approved by the FDA to treat major depression and anxiety disorders.

Risk/Benefit Assessment

Known Potential Risks

Some common effects have rationalized more than 10%, such as headache, nausea, ejaculation disorder, somnolence, and insomnia. Also, there are some common effects with less than 10% incidence, including; abnormal dreams, anisocoria, anxiety, dry mouth, and other effects.

 Psychomotor effects

Fatigue or somnolence is the most common, especially for old adults. 

Discontinuation symptoms

Discontinuation of Escitalopram and Citalopram may result in dysphoric mood, irritability, agitation, anxiety, headache, lethargy, emotional lability, insomnia, and hypomania. Symptoms such as panic attacks, hostility, aggressiveness, impulsivity, akathisia, mania, worsening depression, and suicidal ideation can emerge when the dose is adjusted.

Sexual dysfunction

Common symptoms after stopping these two medications include; genital anesthesia, erectile dysfunction, anhedonia, decreased libido, premature ejaculation, vaginal lubrication issues, and nipple insensitivity in women. Rates are unknown, and there is no established treatment.

Pregnancy

Antidepressant exposure (including Escitalopram and Citalopram) is associated with the following:

• shorter duration of pregnancy (by three days.)
•  increased risk of preterm delivery (by 55%.) 
• lower birth weight (by 75 g.) 

Using this medication during pregnancy is advantageous compared to the negative effects on the baby.

Overdose

Excessive doses of Escitalopram and Citalopram usually cause dyskinesia, hypertonia, and clonus.

Known Potential Benefits

Escitalopram and Citalopram are effective treatments for anxiety and depression.

Assessment of potential risks and benefits.

The known risks and benefits of Escitalopram and Citalopram are mentioned in the study. The participants will be informed of all the risks, side effects, and benefits.

For more information, please find the link in the references. 

Objectives and Endpoints

The endpoint will be the final oral health assessment for the last participant.

STUDY DESIGN

 Overall Design

The study is a two-group, randomized, double-blind, adult (60 to 18) controlled trial. The study will assess the efficacy of Escitalopram and Citalopram in treating mental disorders and patients’ oral health. 

The study will start with a screening phase of up to 30 days and 24-week double-blind study period. The participant’s duration will be 28 weeks, including the screening phase.

We will have a psychologist on the research team to measure the participants’ mental health. According to the mental health scale, we will start with 328 participants with mental disorders, 164 Escitalopram recipients, and 164 placebo recipients. Escitalopram or Citalopram will be taken daily, beginning the first week with 5 mg and then increasing the dose to 10 mg to get used to the side effects of the medication. We will follow all participants with monthly questionnaire to monitor their oral health (The assessment will be continuous by monthly questionnaires through measurement the halitosis, oral inflammation, and dryness), gradually from 1 to 5, 1= normal condition (no rash or any complaint), 5= (frequencies of highly oral inflammation, other complaints)

After 28 weeks from the screening, participants will have a clinical assessment using an oral health scale and breathalyze to check the halitosis before and after the study. This will be the endpoint of the study. 

The participants will continue using this medication depending on the psychologist’s decision for each case. The flow chart for this design is as below.

 Chart 1: Study protocol chart

Scientific Rationale for Study Design

 The study was designed to measure the efficacy of Escitalopram and Citalopram (which are intended for mental disorder patients) on oral health improvement. The medication will be used for the right patient depending on the mental health scale.

Justification for Dose

The dose level of Escitalopram or Citalopram is based on the recommended dose for adults from the manufacturing company. Each medication has three amounts; 5mg, 10mg, and 20mg. Should any patient start with 5mg, raise it gradually depending on the mental health condition by using the mental health scale.

End-of-study Definition

The final visit of the last participant is the end of the study, and the data will be collected at a specific time.

STUDY POPULATION

* The screening for the qualified participants will be within 30 days or less before randomization, and the participants will choose depending on the mental health scale.

* The inclusion and exclusion criteria for enrolling participants in this study are described below.

 Waivers are not allowed.

Inclusion Criteria

The participants must satisfy all of the following criteria to be enrolled in the study:

1- Participants (or their legal representatives) must consent to participate in the study. The consent must indicate an understanding the purpose, procedures, and possible risks or benefits. 

2- Participants must be willing and able to adhere to the prohibitions and restrictions of the study.

3- Participants must be in excellent or stable physical health.

4- Participants must have mental disorders depending on the mental health scale.

5- Participants must do standard oral care at home.

6- Participants should not undergo any oral hygiene treatment during the study.

7- The participants’ age range must be between 18 and 60 when signing the consent form.

8- Participants must be willing to provide verifiable identification and have the means to be contacted.

9- Participants must be able to read, understand, and complete the questionnaires.

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:

1- The participant has an abnormal function of the immune system.

2- Participant with any mental health medications.

3- Participant who is a drug abuser.

4- The participant cannot communicate reliably with the investigator.

5- Participant who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study.

* The study will remain consistent with any new information.

Lifestyle Considerations

Participants must agree to follow all requirements met during the study, as noted in the inclusion and exclusion criteria.

Screen Failures

* The investigator completes the identification of the participants and their enrollment in the study. To be easily referenced during and after the study. The sponsor of the study site will review the document.

 * All participants’ identities will be confidential and placed in the study file; there will be no copy.

* Participants who do not meet the study criteria for enrollment in the study (screen failure)

Strategies for Recruitment and Retention

a) The study.

* Making a plan for the recruitment approach and submitting the documents for the recruitment methods for initial IRB approval.

* Sufficient budget to cover all study aspects, such as the transportation for research volunteers. (being generous).

* Using social media to increase recruitment efficiency by publishing the study brochure, the study logo, and others.

b) The participants.

* Responding to all the volunteers and answering all their inquiries. Also, flexibility in dealing with them through making the examination time commensurate with their time (e.g., in-home vs. clinic, evening appointments).

* Being friendly and confident with participants.

* Saying “thank you” often to the participants.

* Using technology and social media by making the monthly questionnaires via social media.

c) The research team.

* Continuous communication with the research team and sharing updates weekly by meeting with them.

* Using technology and social media by meeting the research team.

* Motivating the research team and being open to discussing what is working and how to improve the strategies.

Statistical Consideration

Statistical Hypothesis

The primary efficacy hypothesis is that Escitalopram or Citalopram improves oral health in adults with mental disorders.

Sample Size Determination

Since there are no previous articles on the efficacy of Escitalopram on oral health improvement, we calculate the sample size by determining the following assumption:

* 80% power to reject the null hypothesis.

* 5% of type I error.

* statistical test is the t-test.

Therefore, the sample size of our study is (328), 164 for each group, calculated using this formula and software calculator.

(z)^2 * p(1-p) / d^2

z= 1.28

p= 0.5

d= 0.05

n= (1.28) ^2 * 0.5(1-0.5) / (0.05) ^2

= 164 per arm.

Statistical Analyses

General Approach

The primary statistical analysis will use a mixed model repeated measures (MMRM) approach to compare the efficacy of Escitalopram or Citalopram to a placebo.

Analysis of the primary efficacy endpoints

The primary efficacy endpoint will be the change in the oral health score from baseline to week 24.

Analysis of the secondary efficacy endpoints

Secondary efficacy endpoints will include changes in oral health scores from baseline to week 12, changes in oral health scores from week 12 to week 24, and changes in other oral health parameters from baseline to week 24.

Baseline Descriptive Statistics

Baseline descriptive statistics will be performed for all participants to compare the characteristics of the Escitalopram versus Citalopram groups.

Planned Interim Statistics

Planned interim analyses will be conducted to assess the safety and efficacy of Escitalopram versus Citalopram.

Subgroup Analyses

Subgroup analyses will also be performed to evaluate the efficacy of Escitalopram or Citalopram in specific subgroups of participants.

Tabulation of Individual Participant Data and Exploratory Analyses

Individual participant data and exploratory analyses will be conducted to investigate potential determinants of the efficacy of Escitalopram versus Citalopram.

Randomization and Blinding

Intervention Allocation

* After the screening period, blocked randomization will be used in this study. Participants will distribute randomly into two groups [ Escitalopram (group 1), placebo (group 2)]. This will be based on a computer-generated randomization schedule prepared before the study.

* Using software systems to define the intervention codes will dictate the intervention assignment for the participants.

Blinding

* This study is double-blind.

* Blinding will be guaranteed by the preparation of the study medication by an unblinded pharmacist or other qualified study-site personnel with primary responsibility for study medication preparation and dispensing by providing the medicine in the same shape and packages.

* The codes will be maintained within the software system. The investigator will not be provided with randomization codes.

* The blinding will be broken once all participants and data have been completed (with normal circumstances).

* In an emergency, the investigator can define the intervention by calling the software system responsible for breaking the intervention code.

* The entire randomization code will be revealed when the study is completed, and the database is closed.

Data Collection

* To ensure accurate data for our study, we will have qualified investigators, personnel study sites, and sponsor monitoring.

* Collection instructions and guidelines completion will provide and review with sponsor personnel before the study.

* Every participant will have a file, and every file will be an e-cope and paper copy. The site file will contain essential details from the initiation of the study to the closeout.

* The participants’ visits assessments will be on paper. It will write by site personnel. The information will enter the system, and the document will be scanned into the participant file. The information will be reviewed to avoid any bias or missing.

* The monthly questionnaires will send to participants as e-copies. When it comes back, the information will enter into the system and print out to save in a paper file.

* There would be qualified site personnel to compare and review information between e-copy and paper copy after saving any new information.

* The sponsor will be the response for monitoring, auditing, and record retinting. The sponsor will also provide direction regarding the design of the research process.

* At the end, the investigator and institution will maintain e- and paper copies of the study. This will be based on the files have already been recorded through the e-copy at the researcher’s end user file.

Safety

* While mild to moderate side effects are expected, AEs that preclude taking the drugs are not anticipated.

*AEs taking any drugs and those who take drugs periodically will be identified, and their data will be recorded separately.

* Unsolicited AEs will be captured for a study period.

* The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the Medical Dictionary for Regulatory Activities.

*All SAs with extreme events will be noted, and their results will be recorded differently to eliminate data bias.

* All SAEs and AEs that result in study discontinuation (regardless of the causal relationship) must be reported from the time the medication is administered until the endpoint.

* Any pregnancy would consider an AE. The participant will undergo monitoring, and the study will continue.

* Depending on what FDA approved for these medications, there is no serious adverse event, but the participants will be instructed to contact the investigators if anything unusual happens.

*The participants will be informed that in case of any emergency, they should visit the ER to ensure there is nothing wrong related to the intervention.

Clinical Trial Monitoring

The sponsor and investigators will closely monitor the study to ensure that participants are adequately informed of the study procedures and risks and that the survey is conducted per protocol. It will be monitored by a third party to ensure the accuracy and integrity of the data collected. Audits will be conducted to ensure compliance with Good Clinical Practice (GCP) guidelines.

Safety Oversight

This study will be monitored by an independent Data Monitoring Committee (DMC) to ensure the safety and efficacy of the study medications. The DMC will be responsible for monitoring safety events and making recommendations on any changes to the protocol or study termination as needed.

References

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