- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05576142
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
Status
Completed
Intervention / Treatment
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Tooth Demineralization
- Tooth Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Dental Caries
- Periodontal Diseases
Other Study ID Numbers
- 2022-PEDORALFINDINGS
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.