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Completed

NCT Number: NCT05576142

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

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.

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Key information

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pavia, Lombardy, 27100, Italy

About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oral examination

Diagnostic Test

Patients underwent oral examination with the recording of DMFT, PSR, PI and presence/absence of mouth breathing.

Primary outcomes

  1. 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
  2. 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.

  3. DMFT - Decayed Missing Filled Teeth Index (WHO, 2013)

    Time frame: Baseline

    Sum of the decayed, missing, filled teeth.

  4. Mouth breathing

    Time frame: Baseline

    Assessment of the presence/absence of mouth breathing.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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