Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPierre Fabre Dermo Cosmetique

About this trial

The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject aged between 18 and 80 years included

Subject having signed his/her written informed consent for his/her participation in the study

Subject diagnosed with active generalized periodontal disease (excluding gingivitis)

Subject having at least 20 natural teeth (10 teeth on each side (right and left))

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test interdental brush

    Other intervention

    Interdental brush to be used twice a day during the whole study.

  • Comparative interdental brush

    Other intervention

    Interdental brush to be used twice a day during the whole study.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Test interdental brushOther 1 intervention
Group B: Comparative interdental brushOther 1 intervention

Trial outcomes

Primary outcomes

1

Effect on dental plaque

Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth.

Time frame
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
2

Effect on gingival bleeding

Gingival bleeding (%) will be assessed on each side of the mouth.

Time frame
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
3

Effect on pocket depth

Pocket depth (mm) will be assessed on each side of the mouth.

Time frame
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
4

Interdental hygiene assessment by subject

Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement)

Time frame
Visit 2 (Day 29).

Secondary outcomes

Other outcomes

Sponsors and contacts

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