NCT07112079

Brief Summary

This study aims to assess parents' knowledge of antibiotic use and its relationship with their children's oral health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 31, 2025

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Parental Knowledge and Beliefs on Antibiotic Use (Knowledge and Beliefs Subscale of the PAPA Scale)

    Evaluation of parents' knowledge level and misbeliefs regarding antibiotic use: This score is obtained from the Knowledge and Beliefs subscale of the PAPA scale and measures the level of knowledge of parents on issues such as the necessity and appropriateness of antibiotics.

    1 month

  • DMFT Index (Decayed, Missing, and Filled Teeth) Score

    The DMFT index assesses the dental caries experience by counting the number of decayed, missing, and filled permanent teeth. Scores range from 0 to 28 (or 32 depending on dentition), where higher scores indicate worse dental health (more caries experience).

    1 month

  • PUFA Index (Pulpal involvement, Ulceration, Fistula, and Abscess) Score

    The PUFA index measures the clinical consequences of untreated dental caries, including pulpal involvement, ulceration, fistula, and abscess formation. Scores range from 0 to 4, where higher scores indicate more severe clinical complications due to untreated caries.

    1 month

Study Arms (2)

Group 1: Children (n=805)

This cross-sectional study included a group of 805 children aged 3 to 14 years. Children's oral health was clinically evaluated using the DMFT (Decayed, Missing, and Filled Teeth) and PUFA (Pulpal involvement, Ulceration, Fistula, and Abscess) indices to provide an objective measure of dental health.

Group 2: Parents (n=805)

This cross-sectional study involved a cohort of 805 parents of children aged 3 to 14 years. The primary objective was to assess parental knowledge and attitudes towards antibiotic use. No interventions were implemented; instead, data were collected using a 45-item questionnaire based on the Parental Perceptions on Antibiotics (PAPA) scale. The PAPA scale evaluates various factors influencing parental decisions regarding antibiotic use, including knowledge, beliefs, behaviors, sources of information, adherence, and awareness of antibiotic resistance . The questionnaire was administered face-to-face to ensure accurate data collection and to facilitate clarification of any questions.

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric population

You may qualify if:

  • Children whose parents were literate in Turkish, enabling reliable communication.
  • Children whose parents had no communication impairments, ensuring accurate data collection.

You may not qualify if:

  • Children who attended the clinic with a legal guardian or relative other than their parents.
  • Children whose parents had inadequate health status preventing successful completion of the questionnaire.
  • Children with any diagnosed mental illness.
  • Children whose parents had any diagnosed mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 8, 2025

Study Start

January 1, 2025

Primary Completion

April 20, 2025

Study Completion

May 20, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations