Trial document





This trial has been registered retrospectively.
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  DRKS00007651

Trial Description

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Title

The influence of the utilization time of different power toothbrushes on oral hygiene assessed over a 6-month observation period: a randomized clinical trial (RCT)

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Trial Acronym

power toothbrush study

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URL of the Trial

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Brief Summary in Lay Language

Background: Aim of this randomized clinical trial (RCT) was to investigate whether the 6-month continuous utilization of different power toothbrushes (TBs) influences plaque removal and gingival inflammation compared to short utilization periods of 4 weeks.
Methods: Seventy-three participants were randomly allocated into two groups: continuous utilization over 6 months (non-renewal group) or renewal of TB every 4 weeks over 6 months (renewal group). Each group was subdivided into three subgroups (groups A-F; n=12 or 13) according to TB used (oscillating-rotating, sonic active and vibrating manual). Plaque accumulation, gingival inflammation and gingival trauma were recorded at the beginn of the study and 2, 8, 12, 16, and 24 weeks after beginn of the study . After 24 weeks, each participant received a new TB. At week 26, plaque accumulation, gingival inflammation and gingival trauma were finally determined. Statistical evaluation was performed.

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Brief Summary in Scientific Language

Background: Aim of this randomized clinical trial (RCT) was to investigate whether the 6-month continuous utilization of different power toothbrushes (TBs) influences plaque removal and gingival inflammation compared to short utilization periods of 4 weeks.
Methods: Seventy-three participants were randomly allocated into two groups: continuous utilization over 6 months (non-renewal group) or renewal of TB every 4 weeks over 6 months (renewal group). Each group was subdivided into three subgroups (groups A-F; n=12 or 13) according to TB used (oscillating-rotating, sonic active and vibrating manual). Modified Quigley-Hein plaque index (QHI), papilla bleeding index (PBI), and gingival index (GI) values were recorded at baseline and 2, 8, 12, 16, and 24 weeks after baseline. After 24 weeks, each participant received a new TB. At week 26, QHI, PBI, and GI were finally determined. Statistical evaluation was based on analysis of covariance (p<0.05).

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Organizational Data

  •   DRKS00007651
  •   2015/01/09
  •   [---]*
  •   yes
  •   Approved
  •   19/03/2007, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   healthy volunteers were included
  •   oral hygiene
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Interventions/Observational Groups

  •   continuous toothbrush utilization over 6 months (non-renewal group): The participants were allocated into three subgroups according to TB used (oscillating-rotating: ProfessionalCare™ 7000, Procter&Gamble Service GmbH, Schwalbach am Taunus, Germany, sonic active: SoniCare™, Philips GmbH, Hamburg, Germany, and vibrating manual: Dr. Best Vibration®, GlaxoSmithKline, Bühl, Germany); over the 6 month observation period, only the test toothbrush, according the group, with one toothpaste was used for the whole study period with twice-daily brushing.
  •   renewal of toothbrush every 4 weeks over 6 months (renewal group): The participants were allocated into three subgroups according to TB used (oscillating-rotating: ProfessionalCare™ 7000, Procter&Gamble Service GmbH, Schwalbach am Taunus, Germany, sonic active: SoniCare™, Philips GmbH, Hamburg, Germany, and vibrating manual: Dr. Best Vibration®, GlaxoSmithKline, Bühl, Germany); over the 6 month observation period, only the test toothbrush, according the group, with one toothpaste was used for the whole study period with twice-daily brushing and renewal of TB every 4 weeks.
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Characteristics

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

end point: plaque accumulation (QHI), gingival inflammation (PBI), gingival trauma (GI)

time of measurement: Baseline and 2, 8, 12, 16, and 24 Wochen after Baseline, as well as finally at week 26

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2007/07/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

caries-free and sufficiently conservatively and prosthetically treated dentition, minimum of 20 of their own teeth, and prevention-oriented behavior.

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Exclusion Criteria

diabetes mellitus, infectious diseases (hepatitis A/B/C, HIV),
renal failure,
seizure or neurological disorders,
addiction (alcohol, drugs),
pregnancy,
required antibiotic prophylaxis due to endocarditis risk or immunosuppression (e.g., due to organ transplantation or rheumatoid arthritis), or fixed orthodontic appliances.

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Addresses

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    • Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  Dr.  Dirk  Ziebolz 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  Dr.  Dirk  Ziebolz 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  Dr.  Dirk  Ziebolz 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen, Poliklinik für Präventive Zahnmedizin, Parodontologie und Kariologie
    • Mr.  Dr.  Dirk  Ziebolz 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/12/31
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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.