- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06709352
Effect of Hypertensive Drugs on Root Caries Among Senior Patients in Cairo University
Association Between Anti-hypertensive Drugs and Root Caries Among Senior Patients Attending Cairo University Dental Educational Hospital : Analytical Cross-Sectional Study
The aim of this analytical cross-sectional study study is to evaluate the prevalence of root caries in senior patients of both genders age of 50 to 70 years old, taking antihypertensive drugs attending the Cairo University Dental Educational Hospital and to consider the association of root caries with antihypertensive drugs. Furthermore, to understand the relationship between risk indicators of root caries and saliva pH that can be a potential etiological factor.
- The main question it aims to answer is: In senior patients attending Cairo University Dental Educational Hospital, what is the prevalence of root caries among patients taking antihypertensive drugs, what are the related risk indicators and how do they correlate with salivary pH?
Study Overview
Detailed Description
Introduction and Scientific Background:
Root caries is a condition that commonly affects the senior population worldwide. It is a result of physiological gingival recession with aging that may be greatly exacerbated by poor oral hygiene. In Egypt, caries prevalence is estimated to be 60-70%. Respondents from multiple countries, including Egypt, reported that the elderly age group (i.e., >60 years old) is considered most susceptible to developing root caries.
Oral conditions like root caries are known to be caused by a number of systemic factors, one of which is hypertension. Hypertension is a long-term medical condition characterised by elevated blood pressure within the arteries. The national estimate for the prevalence of hypertension in Egypt's adult population is 26.3%, making it one of the highest in the world, according to the Egyptian National Hypertension Project (NHP).
When used as a treatment for hypertension, antihypertensive drugs can have a variety of adverse effects on the mouth, including xerostomia and abnormal salivary flow, which may lead to dental caries. Also, numerous negative alterations in the oral cavity can be linked to the impact on stimulated saliva. Although further investigation is necessary to fully comprehend the connection between antihypertensive medications and dental health, these results imply that using these drugs has an impact on oral health and necessitates maintaining proper oral hygiene.
Review of Literature:
A key element of active ageing is health. Root caries is one of the main oral public health issues linked to aging. Over the past forty years, there has been a notable decrease in the number of edentulous people and an increase in the number of natural teeth remaining in the oral cavity, according to periodic dental health surveys.
Because life expectancy has increased over the past few decades, a significant portion of the population is now older. Studies indicate that over half of individuals older than 65 years have experienced root caries. It is also suggested that adults who have lived in fluoridated areas throughout most of their lives, including during tooth formation, have a lower prevalence of root caries.
Findings are consistent with studies estimating that caries prevalence in Egypt is about 60-70%. Egyptian adults are at greater risk of developing caries, with a total prevalence of 86.63%, compared to children and adolescents, for whom a value of 74% was recorded.
Antihypertensive drugs can cause adverse reactions, defined by the World Health Organization as a response to a drug that is noxious and unintended and occurs at doses normally used in humans. These drugs have the potential to cause conditions such as dental caries, salivary gland disease, ulceration, taste alterations, discolouration of teeth, mucosal pigmentation, white lesions, and swellings.
These side effects interfere with the patient's normal function and increase the risk of infection, pain, and possible tooth loss. Common side effects include dental caries, xerostomia, altered taste, and stomatitis. While more research is needed to understand the relationship between antihypertensive drugs and oral health, these findings suggest that taking these medications impacts oral health and therefore requires good oral hygiene maintenance.
Data on the prevalence of root caries among Egyptian seniors are scarce and are mostly found in grey literature, making them difficult to access. The last published report on the prevalence of caries among Egyptian adults was conducted by the World Health Organization in collaboration with the Egyptian Ministry of Health in 2014. Therefore, the current study was carried out to investigate the prevalence of root caries among Egyptian seniors taking antihypertensive drugs in correlation with different risk factors.
Rationale:
The senior age group is becoming a focus of attention in dental community health approaches. They often struggle with lower self-care ability and systemic health conditions such as hypertension. Hypertension and the use of antihypertensive drugs have a definitive effect on the pH levels of stimulated saliva, which can be attributed to many detrimental oral changes such as xerostomia and dental caries.
Around 50% of Egyptians over the age of 60 years have hypertension. Among the elderly, approximately 42% have dental caries, and several cross-sectional studies have found a positive correlation between age and root caries.
It is concluded that the prevalence of root caries increases with age and is greater in the elderly population than in younger adults. Old age can therefore be considered a predictor of root caries, as geriatric individuals usually experience more gingival recession, leading to plaque accumulation and an increased risk of root caries on exposed tooth surfaces.
Researchers believe that many antihypertensive drugs can cause adverse effects in the oral cavity, such as xerostomia and root caries, but the association remains unclear. It is also not determined whether there are associated risk indicators or whether they correlate with the pH levels of stimulated and unstimulated saliva.
This study may help raise awareness among dentists and oral health care providers about dental health and its relation to antihypertensive drugs and their possible side effects among seniors in Egypt. It aims to improve diagnosis and treatment planning, promote attention to seniors within a community health approach, and educate community members.
The questionnaire will help evaluate individual factors affecting patients' caries risk. Patients will better understand the importance of regular dental examinations and the role of empirical therapy in improving quality of life, as well as consider oral health as an essential component of overall health.
External Validity:
- This study could be generalised, as the Faculty of Dentistry at Cairo University is considered a pivotal institution in Cairo governorates.
- The root ICDAS assessment of caries lesions and the questionnaire used (ICDAS root/coronal caries and individual factors in institutionalised elderly) are validated tools that have been previously used to assess the prevalence of carious lesions and associated risk indicators.
- Validation of the questionnaire:
The questionnaire used is considered valid as it is designed similarly to one used in a previously conducted cross-sectional study.
Study Design:
Type of Study:
Analytical cross-sectional study.
Population:
Senior patients aged 50-70 years attending the Diagnostic Central Clinic at Cairo University Dental Educational Hospital.
Exposure:
Antihypertensive drugs.
- Setting:
This study will take place in the postgraduate clinic, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Method of Selection:
Seniors attending the diagnosis clinic at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt, will be examined for their chief complaint. Patients will be enrolled in this study if they meet the eligibility criteria.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Senior patients, age group of 50-70 years old , attending in the diagnosis clinic at Conservative Dentistry department, faculty of dentistry, Cairo University Egypt, will be examined for their chief complaint.
- Patients will be enrolled in this study if they are compatible with eligibility criteria.
Description
Inclusion Criteria:
- Senior patients, age group of 50-70 years old
- Positive subject acceptance for participation in the study
- Taking anti-hypertensive drugs
- Both gender
- Egyptian Nationals
Exclusion Criteria:
- Seniors with dental emergency 12
- Seniors with psychological problem
- Seniors with reported terminal illness or severe mental impairment in the medical records.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of root caries in patients taking anti- hypertensive drugs.
Time Frame: 3 months
|
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Associated risk indicator
Time Frame: 4 months
|
Associated risk indicators for all participants and Salivary assessment regarding pH level for each subgroup diagnosed with root caries lesions.
|
4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.
- Kumara-Raja B, Radha G. Prevalence of root caries among elders living in residential homes of Bengaluru city, India. J Clin Exp Dent. 2016 Jul 1;8(3):e260-7. doi: 10.4317/jced.52682. eCollection 2016 Jul.
- Langari SF, Hosseini SR, Bijani A, Jenabian N, Motalebnejad M, Mahmoodi E, Madani ZS, Sayadi F, Naghibi Sistani M, Ghadimi R, Baladi F, Hajimirzamohammad M, Mehryari M, Shirzad A. Association between antihypertensive drugs and the elderly's oral health- related quality of life: Results of Amirkola cohort study. Caspian J Intern Med. 2022 Summer;13(3):582-588. doi: 10.22088/cjim.13.3.582.
- Valtellini R, Ouanounou A. Management of the Hypertensive Dental Patient. J Can Dent Assoc. 2023 Mar;89:n2.
Helpful Links
- Biostatistics 102: quantitative data--parametric & non-parametric tests
- Streckfus CF, Strahl RC, Welsh S. Anti-hypertension medications: an epidemiological factor in the prevalence of root decay among geriatric patients suffering from hypertension. Clinical Preventive Dentistry. 1990 Aug-Sep;12(3):26-29. PMID: 2150630.
- Jingyang Zhang, Edward Chin Lo et al, (2020), Epidemiology of dental root caries: a review of risk factors, FOMM J.
- Al-Harthy, N. , Qutiesha, A. et al, (2023) : A Preventive Strategy against Root Caries for the General Dentist: A Cross-sectional Clinical Study.Op Dent J, Volume 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Root Caries & Drugs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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