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

NCT ID: NCT06922799

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-05-18

Brief Summary

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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

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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.

Conditions

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Dental Plaque Saliva Altered

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pre-Orthodontic group

Patients from this group are candidate to orthodontic treatment

Saliva-Check Buffer test and periodontal charting

Intervention Type DIAGNOSTIC_TEST

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

Saliva-Check Buffer test and periodontal charting

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Saliva-Check Buffer test and periodontal charting

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2025-SALIVARYPH

Identifier Type: -

Identifier Source: org_study_id

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