Dental PlaqueNCT06922799
A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality
An observational study of Dental Plaque and Saliva Altered, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Saliva Altered
- What is being tested?
- Saliva-Check Buffer test and periodontal charting
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2025to 18 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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:
- 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.
Read the 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:
- 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.
- Conditions
- Dental Plaque, Saliva Altered
- Being tested
- Saliva-Check Buffer test and periodontal charting
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva-Check Buffer test and periodontal chartingDiagnostic test
Saliva-Check buffer test will be used to perform evaluations on saliva pH, quantity and quality
| Study group | Role | What they receive |
|---|---|---|
| Pre-Orthodontic group | Patients from this group are candidate to orthodontic treatment Receives: Diagnostic Test: Saliva-Check Buffer test and periodontal charting | |
| Orthodontic group | Patients from this group are undergoing an orthodontic treatment Receives: Diagnostic Test: Saliva-Check Buffer test and periodontal charting |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMFT (Decayed, Missing, Filled Teeth)
Sum of decayed, missing due to caries, and filled teeth.
Measured: Baseline
DMFS (Decayed, Missing, Filled Surfaces)
Sum of decayed, missing due to caries, and filled tooth surfaces.
Measured: Baseline
PCR (Plaque Control Record)
Number of surfaces with plaque / Total number of surfaces examined) x 100 using disclosing Tri Plaque ID gel.
Measured: 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.
Measured: Baseline
Saliva Check Buffer test
Complete assessment of saliva quality, quantity and pH
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Apr 2025
- Primary completion16 May 2025
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922799
- Sponsor's protocol ID
- 2025-SALIVARYPH
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06922799
- Acronym / sponsor ID
- 2025-SALIVARYPH
- Conditions
- Dental Plaque, Saliva Altered
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Orthodontic group | – | Diagnostic Test: Saliva-Check Buffer test and periodontal chartingPatients from this group are candidate to orthodontic treatment |
| Orthodontic group | – | Diagnostic Test: Saliva-Check Buffer test and periodontal chartingPatients from this group are undergoing an orthodontic treatment |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva-Check Buffer test and periodontal chartingSaliva-Check buffer test will be used to perform evaluations on saliva pH, quantity and quality | Diagnostic test | Orthodontic group, Pre-Orthodontic group |
Primary outcome
DMFT (Decayed, Missing, Filled Teeth)
Time frame: Baseline
Sum of decayed, missing due to caries, and filled teeth.
DMFS (Decayed, Missing, Filled Surfaces)
Time frame: Baseline
Sum of decayed, missing due to caries, and filled tooth surfaces.
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.
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.
Saliva Check Buffer test
Time frame: Baseline
Complete assessment of saliva quality, quantity and pH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque and Saliva Altered, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMFT (Decayed, Missing, Filled Teeth) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.