Clinical trial NCT06922799: A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality
Official title: A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality: Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Plaque
Saliva Altered
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited from the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy

Brief summary: This study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using Saliva-Check Buffer salivary tests. A total of 40 patients will be enrolled, divided into two groups:

1. Group A (Pre-Orthodontic Treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment.
2. Group B (Orthodontic Treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

Detailed description: This study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using Saliva-Check Buffer salivary tests. A total of 40 patients will be enrolled, divided into two groups:

1. Group A (Pre-Orthodontic Treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment.
2. Group B (Orthodontic Treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

Ethical Considerations: the study will be conducted in accordance with the Declaration of Helsinki and the norms of the Good Clinical Practice.

Patient Enrollment: patients meeting the inclusion criteria will be identified from the dental clinic's patient records. Parents or legal guardians will be approached to obtain informed consent for participation in the study.

Baseline Assessment: baseline dental examinations will be conducted to assess the dental health status of each patient, recording the following indexes: DMFT (Decayed, Missing, Filled Teeth), DMFS, PCR. Then, saliva collection and testing will be performed with Saliva-Check Buffer.

Data Analysis: data will be statistically analysed. Normality test will be performed, and a parametric or non-parametric test will be performed to compare the two groups for all the variables tested. Significance threshold will be predefined for p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Patients about to begin orthodontic treatment or already undergoing orthodontic therapy
* Willingness to undergo Saliva-Check Buffer salivary tests.
* Parental or legal guardian consent for participation in the study.

Exclusion Criteria:

* Patients with systemic medical conditions that may affect the results of salivary tests.
* Patients unwilling or unable to cooperate for saliva sample collection required for the tests.
* Patients who have taken antibiotics or other medications that could influence saliva composition in the weeks prior to testing.
* Patients with oral anomalies that may interfere with data collection or affect test results.

Primary outcomes:
measure: DMFT (Decayed, Missing, Filled Teeth)
timeFrame: Baseline
measure: DMFS (Decayed, Missing, Filled Surfaces)
timeFrame: Baseline
measure: PCR (Plaque Control Record)
timeFrame: Baseline
measure: Frankl Behavioral Scale
timeFrame: Baseline
measure: Saliva Check Buffer test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: