Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma

October 7, 2022 updated by: Andrea Scribante, University of Pavia

Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma: a Cohort Study

The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people.

Study Overview

Detailed Description

The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people. At the oral evaluation, the following indexes were calculated: PSR, Periodontal Screening and Recording; PI, Plaque Control Record and DMFT, Decayed Missing Filled Teeth Index. Absence or presence of mouth breathing was also recorded. Linear regressions were calculated to compare the oral findings with gravity of allergic rhinitis, to asthma compensation and to asthma treatment.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients addressing to the Pediatric clinic of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy for medical care.

Description

Inclusion Criteria:

  • age 5-14 years old
  • presence of allergic rhinitis diagnosed according to ASIA guidelines and/or presence of asthma diagnosed according to GINA guidelines

Exclusion Criteria:

  • refuse to participate to the study
  • presence of systemic diseases that could alter oral conditions (Sjögren syndrome, celiac disease, calcium disorders).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group
Patients from this group were diagnosed from allergic rhinitis and/or asthma.
Patients underwent oral examination with the recording of DMFT, PSR, PI and presence/absence of mouth breathing.
Control Group
Healthy children.
Patients underwent oral examination with the recording of DMFT, PSR, PI and presence/absence of mouth breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSR - Periodontal Screening and Recording (Landry and Jean, 2002)
Time Frame: Baseline

Scoring criteria:

  • 0: Absence of clinical signs
  • 1: Bleeding on probing
  • 2: Supra and/or subgingival calculus and/or defective margins
  • 3: Periodontal pocket 4 mm to 5.5 nm deep (coloured band on probe partially visible)
  • 4: Periodontal pocket 6 mm deep (colored band no longer visible)
  • *: Periodontal abnormalities present
  • X: Sextant absent or fewer than 2 teeth
Baseline
PCR - Plaque Control Record (O' Leary et al., 1972)
Time Frame: Baseline
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Baseline
DMFT - Decayed Missing Filled Teeth Index (WHO, 2013)
Time Frame: Baseline
Sum of the decayed, missing, filled teeth.
Baseline
Mouth breathing
Time Frame: Baseline
Assessment of the presence/absence of mouth breathing.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, MSc, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 25, 2022

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data are available upon request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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