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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05576142
Other study ID # 2022-PEDORALFINDINGS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date January 25, 2022

Study information

Verified date October 2022
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 25, 2022
Est. primary completion date January 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 14 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Italy Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Pavia Lombardy

Sponsors (1)

Lead Sponsor Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary DMFT - Decayed Missing Filled Teeth Index (WHO, 2013) Sum of the decayed, missing, filled teeth. Baseline
Primary Mouth breathing Assessment of the presence/absence of mouth breathing. Baseline
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