Allergic RhinitisNCT05576142
Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
An observational study of Allergic Rhinitis and Asthma in Children, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Asthma in Children, Dental Caries
- What is being tested?
- Oral examination
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 25 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients addressing to the Pediatric clinic of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy for medical care.
Who may be able to join
- age 5-14 years old
- presence of allergic rhinitis diagnosed according to ASIA guidelines and/or presence of asthma diagnosed according to GINA guidelines
Who cannot join
- refuse to participate to the study
- presence of systemic diseases that could alter oral conditions (Sjögren syndrome, celiac disease, calcium disorders).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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.
Read the 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.
- Being tested
- Oral examination
- Medical subject headings
- Rhinitis, Allergic, Dental Caries, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral examinationDiagnostic test
Patients underwent oral examination with the recording of DMFT, PSR, PI and presence/absence of mouth breathing.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Patients from this group were diagnosed from allergic rhinitis and/or asthma. Receives: Diagnostic Test: Oral examination | |
| Control Group | Healthy children. Receives: Diagnostic Test: Oral examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline
DMFT - Decayed Missing Filled Teeth Index (WHO, 2013)
Sum of the decayed, missing, filled teeth.
Measured: Baseline
Mouth breathing
Assessment of the presence/absence of mouth breathing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Sep 2019
- Primary completion15 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MSc, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576142
- Sponsor's protocol ID
- 2022-PEDORALFINDINGS
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma: a Cohort Study
- ClinicalTrials.gov ID
- NCT05576142
- Acronym / sponsor ID
- 2022-PEDORALFINDINGS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: Oral examinationPatients from this group were diagnosed from allergic rhinitis and/or asthma. |
| Control Group | – | Diagnostic Test: Oral examinationHealthy children. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients addressing to the Pediatric clinic of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy for medical care.
Key inclusion criteria (2 listed)
- age 5-14 years old
- presence of allergic rhinitis diagnosed according to ASIA guidelines and/or presence of asthma diagnosed according to GINA guidelines
Key exclusion criteria (2 listed)
- refuse to participate to the study
- presence of systemic diseases that could alter oral conditions (Sjögren syndrome, celiac disease, calcium disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral examinationPatients underwent oral examination with the recording of DMFT, PSR, PI and presence/absence of mouth breathing. | Diagnostic test | Case Group, Control Group |
Primary outcome
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
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.
DMFT - Decayed Missing Filled Teeth Index (WHO, 2013)
Time frame: Baseline
Sum of the decayed, missing, filled teeth.
Mouth breathing
Time frame: Baseline
Assessment of the presence/absence of mouth breathing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No. Data are available upon request to the Principal Investigator.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, MSc principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Asthma in Children, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSR - Periodontal Screening and Recording (Landry and Jean, 2002) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.