Trial document




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  DRKS00017662

Trial Description

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Title

Clinical feasibility study for periodontal diagnostics using intraoral scanners

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The project includes the observation of patients with periodontitis. The study participants will be observed during periodontitis therapy and in the subsequent supportive therapy. For all study participants who receive the standardized standard periodontitis therapy, virtual impressions will be taken with intraoral scanners (IOS) over a period of 18 months at each examination appointment. The aim of the study is to record volume changes in the area of the gums of natural teeth and dental implants over time and thus provide initial evidence of the effectiveness of the use of IOSs as a supplementary diagnostic tool in the diagnosis of periodontal diseases and in monitoring after periodontitis and periimplantitis therapy.

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Brief Summary in Scientific Language

The project includes the prospective observation of patients who have previously received periodontal therapy and are participating Supportive Periodontal Therapy (SPT) and another group of patients who are observed during active periodontal therapy and in the subsequent SPT. For all study participants, virtual impressions using intraoral scanners (IOS) are taken over a period of 18 months at each examination appointment in addition to the standard measures. The primary target parameters of the examination are the periodontal probing depths and attachment level loss over a period of 18 months, as well as volume changes in the gingival area of natural teeth and dental implants when comparing digital impressions over time. The aim of this clinical feasibility study is to provide initial evidence on the effectiveness of the use of IOSs as a complementary diagnostic tool in the diagnosis of periodontal disease and in monitoring after periodontitis and periimplantitis therapy. Secondary target parameters are volume changes of the gingiva during active periodontitis therapy (APT), patient comfort, all findings of the clinical dental examination (number of teeth, restorations and dental prostheses, bleeding or pus exudation on probing, clinically visible signs of inflammation) and duration of intraoral imaging.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

On request, anonymized data and the study protocol can be made available for meta-analyses on the topic.

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Organizational Data

  •   DRKS00017662
  •   2019/09/09
  •   [---]*
  •   yes
  •   Approved
  •   S-455/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1237-8605 
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Health Condition or Problem studied

  •   K05 -  Gingivitis and periodontal diseases
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Interventions/Observational Groups

  •   In patients undergoing supportive periodontal therapy, virtual impressions are taken over an observation period of 18 months during each session.
  •   In patients who have not previously received periodontal therapy, the active periodontal therapy and subsequent adjuvant periodontal therapy virtual impressions are taken over an observation period of 18 month during each session.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome parameters of the examination are the periodontal probing depths and attachment level loss over a period of 18 months, as well as volume changes in the gingival area of natural teeth and dental implants when comparing digital impressions over time.

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Secondary Outcome

Secondary outcome parameters are volume changes of the gingiva during active periodontitis therapy, patient comfort, all findings of the clinical dental examination (number of teeth, restorations and dental prostheses, bleeding or pus on probing, clinically visible signs of inflammation) and duration of intraoral images.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/01/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis: Periodontitis or condition after periodontitis therapy

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Exclusion Criteria

Limited ability to consent, less than 12 teeth present

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Addresses

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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.