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NCT Number: NCT06752902

Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment

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

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Key information

Conditions

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rance Orthodontics Practice, Dinan, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.

Exclusion criteria

  • 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

Treatment and study plan

Standard Care Arm

Other

standard care combined with personalised prevention

standard care combined with personalised prevention

Other

standard care combined with personalised prevention

Primary outcomes

  1. bacteria in biofilm

    Time frame: At inclusion

    number of pathogenic bacteria measured in the biofilm

  2. bacteria in biofilm

    Time frame: At 3 months

    number of pathogenic bacteria measured in the biofilm

  3. bacteria in biofilm

    Time frame: At 6 months

    number of pathogenic bacteria measured in the biofilm

  4. bacteria in biofilm

    Time frame: At 9 months

    number of pathogenic bacteria measured in the biofilm

  5. bacteria in biofilm

    Time frame: At 12 months

    number of pathogenic bacteria measured in the biofilm

  6. viruses in biofilm

    Time frame: At inclusion

    number of viruses measured in the biofilm

  7. viruses in biofilm

    Time frame: At 3 months

    number of viruses measured in the biofilm

  8. viruses in biofilm

    Time frame: At 6 months

    number of viruses measured in the biofilm

  9. viruses in biofilm

    Time frame: At 9 months

    number of viruses measured in the biofilm

  10. viruses in biofilm

    Time frame: At 12 months

    number of viruses measured in the biofilm

Secondary outcomes

  1. patient's satisfaction

    Time frame: at 12 months

    Patient satisfaction on a numerical scale from 0 to 10.

  2. measurement of immune response

    Time frame: At inclusion

    assay of salivary cytokines in ng/ml

  3. measurement of immune response

    Time frame: At 3 months

    assay of salivary cytokines in ng/ml

  4. measurement of immune response

    Time frame: At 6 months

    assay of salivary cytokines in ng/ml

  5. measurement of immune response

    Time frame: At 9 months

    assay of salivary cytokines in ng/ml

  6. measurement of immune response

    Time frame: At 12 months

    assay of salivary cytokines in ng/ml

  7. plaque index

    Time frame: through study completion, an average of 1 year

    scale QHI: quigley hein index

  8. gingival index,

    Time frame: through study completion, an average of 1 year

    gingival index mesured with Ginigical Index Loe&Silness scale

  9. toothbrush wear

    Time frame: through study completion, an average of 1 year

    toothbrush wear with the Toothbrush Wear Index (TWI)

Study contacts

Contact information is provided by the study sponsor or research team.

laurence LUPI, PUPH

CONTACT

[email protected]

3392033272

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study

Acronym: PREPERMIO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 31, 2024
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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