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

A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality: Cross-sectional Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Plaque; Saliva Altered
• Intervention / Treatment: Diagnostic test: Saliva-Check Buffer test and periodontal charting

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Andrea Scribante, DDS, PhD; Phone Number: +39 0382516223; Email: andrea.scribante@unipv.it

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Orthodontic group; Patients from this group are candidate to orthodontic treatment	Diagnostic test: Saliva-Check Buffer test and periodontal charting; Saliva-Check buffer test will be used to perform evaluations on saliva pH, quantity and quality
Orthodontic group; Patients from this group are undergoing an orthodontic treatment	Diagnostic test: Saliva-Check Buffer test and periodontal charting; Saliva-Check buffer test will be used to perform evaluations on saliva pH, quantity and quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Saliva Check Buffer test	Complete assessment of saliva quality, quantity and pH	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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 4, 2025

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: 2025-SALIVARYPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No