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

Completed

• Conditions: Dental Plaque; Saliva Altered

• Registration Number: NCT06922799
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-11
• Study Start: 2025-04-15
• Status Verified: 2025-05
• Primary Completion: 2025-05-16
• Study Completion: 2025-05-18
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DMFT (Decayed, Missing, Filled Teeth)	Baseline	Sum of decayed, missing due to caries, and filled teeth.
DMFS (Decayed, Missing, Filled Surfaces)	Baseline	Sum of decayed, missing due to caries, and filled tooth surfaces.
PCR (Plaque Control Record)	Baseline	Number of surfaces with plaque / Total number of surfaces examined) x 100 using disclosing Tri Plaque ID gel.
Frankl Behavioral Scale	Baseline	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.
Saliva Check Buffer test	Baseline	Complete assessment of saliva quality, quantity and pH

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy