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Root CariesNCT06709352

Effect of Hypertensive Drugs on Root Caries Among Senior Patients in Cairo University

An observational study of Root Caries and Antihypertensive Drugs, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Root Caries, Antihypertensive Drugs
What is being tested?
non
How many people
209 participants
Where
1 siteEgypt
Study dates
1 Feb 2025to 30 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Seniors with dental emergency 12
  • Seniors with psychological problem
  • Seniors with reported terminal illness or severe mental impairment in the medical records.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry

    Cairo

Other trials in Egypt

About this study

Official title: 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?
Read the 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:

  1. This study could be generalised, as the Faculty of Dentistry at Cairo University is considered a pivotal institution in Cairo governorates.
  2. 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.
  3. 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:

  1. Type of Study: Analytical cross-sectional study.
  2. Population: Senior patients aged 50-70 years attending the Diagnostic Central Clinic at Cairo University Dental Educational Hospital.
  3. Exposure: Antihypertensive drugs.
  4. 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.

Being tested
non
Medical subject headings
Root Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nonOther

    non

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of root caries in patients taking anti- hypertensive drugs.

    1. Prevalence of root caries measured by using the index of the root (R) 'ICDAS' assessment of caries lesions: Facial, mesial, distal, Lingual root surfaces of each tooth as one score/surface (decayed /filled) and its codes.
    2. Unit of measurement is:
    • Score E and 0 will be considered as root caries free and the rest of scores will be counted as root caries, Scores expressed as frequency and Percentages.
    1. The instrument used is: The root (R) ICDAS assessment of caries lesions using the Community Periodontal Index (CPI) probe with 0.5mm round tip.
    2. Participants included: All participants under inclusion criteria.

    Measured: 3 months

Secondary outcomes (1)
  1. Associated risk indicator

    Associated risk indicators for all participants and Salivary assessment regarding pH level for each subgroup diagnosed with root caries lesions.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 Feb 2025
  3. Primary completion1 Apr 2025
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709352
Sponsor's protocol ID
Root Caries & Drugs
Status last verified
Mar 2026
First submitted
22 Nov 2024
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27398175
  • 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.

    PubMed 27672245
  • 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.

    PubMed 35974945
  • Valtellini R, Ouanounou A. Management of the Hypertensive Dental Patient. J Can Dent Assoc. 2023 Mar;89:n2.

    PubMed 37098279

Questions about this trial

What is this clinical trial studying?

An observational study of Root Caries and Antihypertensive Drugs, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of root caries in patients taking anti- hypertensive drugs. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06709352, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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