NCT06709352

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

November 22, 2024

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (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. 3. The instrument used is: The root (R) ICDAS assessment of caries lesions using the Community Periodontal Index (CPI) probe with 0.5mm round tip. 4. Participants included: All participants under inclusion criteria.

    3 months

Secondary Outcomes (1)

  • Associated risk indicator

    4 months

Interventions

nonOTHER

non

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 27398175BACKGROUND
  • 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.

    PMID: 27672245BACKGROUND
  • 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.

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

    PMID: 37098279BACKGROUND

Related Links

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nuha Abdelrahman Abdelhai Elhaj (DDS)

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 29, 2024

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

January 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations