OrthodonticsPREPERMIONCT06752902
Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment
A study of Orthodontics, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Oral dysbiosis systematically develops during orthodontic treatment [35][36]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene [37]: A group benefiting from intensive personalised prevention A… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Orthodontics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 6 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.
Who cannot join
- Tobacco;
- Overcrowded restorations, untreated caries,
- lack of tooth mineralisation;
- Medical pathologies;
- Known immunodepression (congenital or acquired);
- Taking a treatment that may induce general immunodepression;
- Taking a probiotic;
- Taking a concomitant treatment that may interact with oral health
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Rance Orthodontics Practice
Dinan, 22100
Olivier Sorel
olivier SOREL
Nice university hospital
Nice, 06000
Laurence LUPI, PUPH, +33492033270, laurence.lupi@univ-cotedazur.fr
laurence LUPI
About this study
Official title: Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
Oral dysbiosis systematically develops during orthodontic treatment [35][36]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene [37]:
- A group benefiting from intensive personalised prevention
- A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics.
Read more
Based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined.
It was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment
- Conditions
- Orthodontics
- Being tested
- Standard Care Arm, standard care combined with personalised prevention
- Keywords
- oral dysbiosis, orthodontics, oral microbiotis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care ArmOther
standard care combined with personalised prevention
standard care combined with personalised preventionOther
standard care combined with personalised prevention
| Study group | Role | What they receive |
|---|---|---|
| patient with standard care | Other | patient with standard care Receives: Other: Standard Care Arm |
| patient with standard care combined with personalised prevention | Other | patient with standard care combined with personalised prevention Receives: Other: standard care combined with personalised prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Measured: At inclusion
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Measured: At 3 months
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Measured: At 6 months
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Measured: At 9 months
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Measured: At 12 months
viruses in biofilm
number of viruses measured in the biofilm
Measured: At inclusion
viruses in biofilm
number of viruses measured in the biofilm
Measured: At 3 months
viruses in biofilm
number of viruses measured in the biofilm
Measured: At 6 months
viruses in biofilm
number of viruses measured in the biofilm
Measured: At 9 months
viruses in biofilm
number of viruses measured in the biofilm
Measured: At 12 months
Secondary outcomes (9)
patient's satisfaction
Patient satisfaction on a numerical scale from 0 to 10.
Measured: at 12 months
measurement of immune response
assay of salivary cytokines in ng/ml
Measured: At inclusion
measurement of immune response
assay of salivary cytokines in ng/ml
Measured: At 3 months
measurement of immune response
assay of salivary cytokines in ng/ml
Measured: At 6 months
measurement of immune response
assay of salivary cytokines in ng/ml
Measured: At 9 months
measurement of immune response
assay of salivary cytokines in ng/ml
Measured: At 12 months
plaque index
scale QHI: quigley hein index
Measured: through study completion, an average of 1 year
gingival index,
gingival index mesured with Ginigical Index Loe\&Silness scale
Measured: through study completion, an average of 1 year
toothbrush wear
toothbrush wear with the Toothbrush Wear Index (TWI)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion6 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752902
- Sponsor's protocol ID
- 23-AOI-04
- Acronym
- PREPERMIO
- Status last verified
- May 2025
- First submitted
- 11 Oct 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
- ClinicalTrials.gov ID
- NCT06752902
- Acronym / sponsor ID
- PREPERMIO / 23-AOI-04
- Conditions
- Orthodontics
- Keywords
- oral dysbiosis, orthodontics, oral microbiotis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 6 Jun 2028 (estimated)
- First posted
- 31 Dec 2024 (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.
Oral dysbiosis systematically develops during orthodontic treatment [35][36]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene [37]:
- A group benefiting from intensive personalised prevention
- A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics.
Based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined.
It was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with standard care | Other | Other: Standard Care Armpatient with standard care |
| patient with standard care combined with personalised prevention | Other | Other: standard care combined with personalised preventionpatient with standard care combined with personalised prevention |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.
Key exclusion criteria (8 listed)
- Tobacco;
- Overcrowded restorations, untreated caries,
- lack of tooth mineralisation;
- Medical pathologies;
- Known immunodepression (congenital or acquired);
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 |
|---|---|---|
| Standard Care Armstandard care combined with personalised prevention | Other | patient with standard care |
| standard care combined with personalised preventionstandard care combined with personalised prevention | Other | patient with standard care combined with personalised prevention |
Primary outcome
bacteria in biofilm
Time frame: At inclusion
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
Time frame: At 3 months
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
Time frame: At 6 months
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
Time frame: At 9 months
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
Time frame: At 12 months
number of pathogenic bacteria measured in the biofilm
viruses in biofilm
Time frame: At inclusion
number of viruses measured in the biofilm
viruses in biofilm
Time frame: At 3 months
number of viruses measured in the biofilm
viruses in biofilm
Time frame: At 6 months
number of viruses measured in the biofilm
viruses in biofilm
Time frame: At 9 months
number of viruses measured in the biofilm
viruses in biofilm
Time frame: At 12 months
number of viruses measured in the biofilm
9 secondary outcomes
patient's satisfaction
Time frame: at 12 months
measurement of immune response
Time frame: At inclusion
measurement of immune response
Time frame: At 3 months
measurement of immune response
Time frame: At 6 months
measurement of immune response
Time frame: At 9 months
measurement of immune response
Time frame: At 12 months
plaque index
Time frame: through study completion, an average of 1 year
gingival index,
Time frame: through study completion, an average of 1 year
toothbrush wear
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Orthodontics, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 1 inclusion and 8 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: opening soon, 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 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact laurence LUPI, PUPH (3392033272, laurence.lupi@univ-cotedazur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacteria in biofilm (time frame: At inclusion). The study lists 10 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.