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
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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COMPLETED
40 participants
OBSERVATIONAL
2025-04-15
2025-05-18
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Willingness to undergo Saliva-Check Buffer salivary tests.
* Parental or legal guardian consent for participation in the study.
Exclusion Criteria
* 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.
6 Years
14 Years
ALL
Yes
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, 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
Countries
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Other Identifiers
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2025-SALIVARYPH
Identifier Type: -
Identifier Source: org_study_id
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