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

NCT06922799 | Completed

• 1 other identifier: 2025-SALIVARYPH
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.Group B (Orthodontic Treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

Conditions

Dental Plaque; Saliva Altered

Outcome Measures

Primary Outcomes (5)

• DMFT (Decayed, Missing, Filled Teeth)

  Sum of decayed, missing due to caries, and filled teeth.

  Baseline

• DMFS (Decayed, Missing, Filled Surfaces)

  Sum of decayed, missing due to caries, and filled tooth surfaces.

  Baseline

• PCR (Plaque Control Record)

  Number of surfaces with plaque / Total number of surfaces examined) x 100 using disclosing Tri Plaque ID gel.

  Baseline

• Frankl Behavioral Scale

  Classification of patients based on cooperation during treatment, using a scale from 1 to 4: * 1: Definitely positive Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation. * 2: Positive Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. * 3: Negative Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn. * 4: Definitely negative Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.

  Baseline

• Saliva Check Buffer test

  Complete assessment of saliva quality, quantity and pH

  Baseline

Study Arms (2)

Pre-Orthodontic group

Patients from this group are candidate to orthodontic treatment

Diagnostic Test: Saliva-Check Buffer test and periodontal charting

Orthodontic group

Patients from this group are undergoing an orthodontic treatment

Diagnostic Test: Saliva-Check Buffer test and periodontal charting

Interventions

Saliva-Check Buffer test and periodontal charting DIAGNOSTIC_TEST

Saliva-Check buffer test will be used to perform evaluations on saliva pH, quantity and quality

Orthodontic group; Pre-Orthodontic group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: April 15, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 18, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)