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NCT Number: NCT06922799

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

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.

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Key information

Conditions

Dental Plaque Dental Deposits Saliva Altered Stomatognathic Diseases Tooth Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pavia, Lombardy, 27100, Italy

About this 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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. DMFT (Decayed, Missing, Filled Teeth)

    Time frame: Baseline

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

  2. DMFS (Decayed, Missing, Filled Surfaces)

    Time frame: Baseline

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

  3. PCR (Plaque Control Record)

    Time frame: Baseline

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

  4. Frankl Behavioral Scale

    Time frame: 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.

  5. Saliva Check Buffer test

    Time frame: Baseline

    Complete assessment of saliva quality, quantity and pH

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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