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A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality

U

University of Pavia

Status

Completed

Conditions

Dental Plaque
Saliva Altered

Treatments

Diagnostic Test: Saliva-Check Buffer test and periodontal charting

Study type

Observational

Funder types

Other

Identifiers

NCT06922799
2025-SALIVARYPH

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

6 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Pre-Orthodontic group
Description:
Patients from this group are candidate to orthodontic treatment
Treatment:
Diagnostic Test: Saliva-Check Buffer test and periodontal charting
Orthodontic group
Description:
Patients from this group are undergoing an orthodontic treatment
Treatment:
Diagnostic Test: Saliva-Check Buffer test and periodontal charting

Trial contacts and locations

1

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Central trial contact

Andrea Scribante, DDS, PhD

Data sourced from clinicaltrials.gov

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