NCT05576142

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration 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

September 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

October 7, 2022

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • PSR - Periodontal Screening and Recording (Landry and Jean, 2002)

    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)

    % 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)

    Sum of the decayed, missing, filled teeth.

    Baseline

  • Mouth breathing

    Assessment of the presence/absence of mouth breathing.

    Baseline

Study Arms (2)

Case Group

Patients from this group were diagnosed from allergic rhinitis and/or asthma.

Diagnostic Test: Oral examination

Control Group

Healthy children.

Diagnostic Test: Oral examination

Interventions

Oral examinationDIAGNOSTIC_TEST

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

Case GroupControl Group

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Rhinitis, AllergicDental CariesPeriodontal Diseases

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesTooth DemineralizationTooth DiseasesStomatognathic DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Andrea Scribante, DDS, PhD, MSc

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

September 1, 2019

Primary Completion

January 15, 2022

Study Completion

January 25, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Data are available upon request to the Principal Investigator.

Locations