Trial document




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  DRKS00011109

Trial Description

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Title

Comparison of the cleaning effectiveness of the Philips Sonicare AirFloss Ultra (HX 8331/51) and the miradent I-Prox® P bursh used for the prevention of gingivitis and caries during orthodontic treatments with fixed appliances

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study aims at a thorough comparison of the Philips Sonicare AirFloss Ultra and the miradent I-Prox P concerning the removal of plaque and the improvement of a plaque-induced gingivitis. The basis for comparison will be patients with fiexed orthodontic appliances. This will ultimately allow for an assessment of the effectiveness of the AirFloss Ultra in the prophylaxis of caries and gingivitis. This effectiveness will then be compared to the miradent I-prox P brush. In addition, this study will further assess the usability and user-friendliness of both products and will develop recommendations for patients with multibracket- appliances in order to reduce and prevent the gingivitis and caries prevalence.

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Brief Summary in Scientific Language

This study aims at a thorough comparison of the Philips Sonicare AirFloss Ultra and the miradent I-Prox P concerning the removal of plaque and the improvement of a plaque-induced gingivitis. The basis for comparison will be patients with fiexed orthodontic appliances. The combination of both short-term and long-term observations will be used to qualify whether the duration of using such cleaning appliances has an effect on the quantity and quality of the plaque removal and the reduction of gingivitis. This will ultimately allow for an assessment of the effectiveness of the AirFloss Ultra in the prophylaxis of caries and gingivitis. This effectiveness will then be compared to the miradent I-prox P brush. In addition, this study will further assess the usability and user-friendliness of both products and will develop recommendations for patients with multibracket- appliances in order to reduce and prevent the gingivitis and caries prevalence.

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Organizational Data

  •   DRKS00011109
  •   2016/09/26
  •   [---]*
  •   yes
  •   Approved
  •   166/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
  •   K05.0 -  Acute gingivitis
  •   K05.1 -  Chronic gingivitis
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Interventions/Observational Groups

  •   1. Appointment :
    screening
    determination of indexes: degree of accumulated plaque and bleedings
    decision on whether to include the patient into the study depending on the PI- values
    decision which group to allocate the patient to, either A (AirFloss) or B (I-Prox)
    instructions on how to use the test products, hand out of AirFloss or I- Prox P brush for the patient to take home; the patient will be asked to familiarize with the product until the next appointment in 12 ± 2 days
    In order to achieve an equal allocation of test participants, the probands will be allocated to the two test groups.

    2. Appointment : Tooth Cleaning after 12± 2 days
    Group A and Group B
    determination of indexes
    tooth cleaning through the test administration to establish a standardized and equal status of oral hygiene before starting the 48h plaque growth phase

    The next appointment will be set up 48h later. In the meantime, the patient will be asked to neither brush the teeth nor use the AirFloss or I-Prox brush. This is necessary to ensure a standardized and approximately equal amount of plaque across participants.

    3. Appointment : Single-use
    Group A and Group B
    determination of indexes
    The patient will be asked to clean all teeth with brackets and bands for four minutes (either with the AirFloss or the brush) and to switch the quadrant in a clockwise direction after one minute.
    repeated determination of indexes

    Long-term Observation
    Six weeks after the third appointment the proband will be asked to come in for another appointment. During these six weeks the patient will be requested to brush his/ her teeth for four minutes every day with the respective test product.

    4. Appointment
    determination of Indexes
    tooth cleaning
    patient will fill out a questionnaire
    The fourth appointment will be used to assess the patients' compliance after having cleaned their teeth for six weeks on their own. It will be assessed to which degree the intensity and care taken in the process of cleaning have changed in correlation with the usage frequency and user experience with the test products. The results of this appointment will then be compared to the results of the single-use study. The subjective experience of patients will be assessed through a questionnaire.
  •   see arm 1: the same number of appointments
    Allocation to the two test groups: Group A: AirFloss Ultra, Philips Sonicare
    Group B: I-Prox P brush, miradent
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   IIIb
  •   N/A
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Primary Outcome

Two indices will be used to measure the plaque accumulation (modified plaque index according to Silness & Loe) as well as the intensity and extent of oral bleedings ( papillary bleeding index) at the different regions ( interdental, around the orthodontic appliances, marginal) with a blunt probe.

number of measurements: a total of 4 measurements:

1. Appointment :
screening
determination of indexes: degree of accumulated plaque and bleedings
decision on whether to include the patient into the study depending on the PI- values
decision which group to allocate the patient to, either A (AirFloss) or B (I-Prox)
instructions on how to use the test products, hand out of AirFloss or I- Prox P brush for the patient to take home; the patient will be asked to familiarize with the product until the next appointment in 12± 2 days
In order to achieve an equal allocation of test participants, the probands will be allocated to the two test groups.

2. Appointment : Tooth Cleaning after 12± 2 days
Group A and Group B
determination of indexes
tooth cleaning through the test administration to establish a standardized and equal status of oral hygiene before starting the 48h plaque growth phase

The next appointment will be set up 48h later. In the meantime, the patient will be asked to neither brush the teeth nor use the AirFloss or I-Prox brush. This is necessary to ensure a standardized and approximately equal amount of plaque across participants.

3. Appointment : Single-use
Group A and Group B
determination of indexes
The patient will be asked to clean all teeth with brackets and bands (either with the AirFloss or the brush) for four minutes and to switch the quadrant in a clockwise direction after one minute.
repeated determination of indexes

Long-term Observation
Six weeks after the third appointment the proband will be asked to come in for another appointment. During these six weeks the patient will be requested to brush his/ her teeth for four minutes every day with the respective test product.

4. Appointment
determination of indexes
tooth cleaning
patient will fill out a questionnaire
The fourth appointment will be used to assess the patients' compliance after having cleaned their teeth for six weeks on their own. It will be assessed to which degree the intensity and care taken in the process of cleaning have changed in correlation with the usage frequency and user experience with the test products. The results of this appointment will then be compared to the results of the single-use study. The subjective experience of patients will be assessed through a questionnaire.

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Secondary Outcome

after the 4th appointment: The subjective experience of patients will be assessed through a questionnaire. Some examples: handling, reachability of difficult Areas and tooth Groups, cleaning efficiency

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/10/10
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   30   Years
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Additional Inclusion Criteria

patients with fixed orthodontic appliances
age: 12- 30 years, teeth of permanent dentition
declaration of consent (parents and proband)
only patients with metallic elements in their orthodontic appliance
plaque index at first appointment: ≥1

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Exclusion Criteria

generalized disease
physical and mental handicap, which restricts physical and cognitive skills
allergic reaction to substances used in the test process (e.g. abrasive polishing paste)
missing declaration of consent
gingival hyperplasia
poor compliance

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Addresses

  • start of 1:1-Block address primary-sponsor
    • OÄ der Abteilung für Zahnerhaltung und Präventive Zahnmedizin
    • Ms.  Priv. Doz. Dr. med. dent  Mozghan  Bizhang 
    • Alfred- Herrhausen- Straße 44
    • 58448  Witten
    • Germany
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  • start of 1:1-Block address scientific-contact
    • OÄ der Abteilung für Zahnerhaltung und Präventive Zahnmedizin
    • Ms.  Priv. Doz. Dr. med. dent  Mozghan  Bizhang 
    • Alfred- Herrhausen- Straße 44
    • 58448  Witten
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Universität Witten/ Herdecke
    • Ms.  Carolin  Winkler 
    • Bachstraße 14
    • 58452  Witten
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.