Trial document




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  DRKS00012510

Trial Description

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Title

Risk Factors for Failure in the Management of Carious Cervical Lesions (Class V) in General Dental Practices

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Regarding the treatment and restoration of active cervical root caries lesions (tertiary prevention) several clinical studies have been published (De Moor et al., 2011; Levy and Jensen, 1990; Lo et al., 2006; McComb et al., 2002; Wood et al., 1993). However, due to inhomogeneous methodology and techniques as well as a relatively short follow-up time of 24 months risk factors for clinical failures were not presented (Hayes et al., 2014). Furthermore, the five studies included ‘only’ 629 active carious cervical lesions in a total of 269 patients. Cumulative failure rates after 24 months between the different restorative materials as well as for the same material among various studies differed widely (Hayes et al., 2014).

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Organizational Data

  •   DRKS00012510
  •   2017/06/09
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  •   yes
  •   No approval required according to EC
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Secondary IDs

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Health Condition or Problem studied

  •   K02 -  Dental caries
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Interventions/Observational Groups

  •   The following data were collected anonymously (without reference to patient names) from the electronic patient files (period 1996 - 2014) meeting the inclusion criteria:
    • private practice/dentist
    • characteristics of the involved tooth and the dentition including the tooth-localization
    • restored tooth surfaces (one-, two-, three-surface restoration)
    • number of teeth (per patient) being included in the study
    • number of the remaining teeth,
    • date of the first visit,
    • date of the last visit,
    • date of the detection of the CCL,
    • DMFT/S at the date of first CCL detection,
    • date of the first and second restorative intervention (on the cervical surfaces) - if present - including information such as the type of intervention/restoration (e.g. filling, crown, extraction)
    • restoration material,
    • age and sex,
    • number of the regular check-ups during observation period,
    • risk level of caries (only the DMFT at a respective age was taken into account [18, 19])

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
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  •   N/A
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Primary Outcome

inactive cervical (root) caries lesions: visual-tactile assessment of sucess for non-invasive treatments (monitoring only or plus local fluoridation) after up to 10 years

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/07/01
  •   4000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   99   Years
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Additional Inclusion Criteria

1. The investigation/treatment period was between 1996 and 2014
2.restorative treatment for active CCLs had also be done at least 6 months before the last recall visit,
3.the cervical (root) caries lesion was solely located on the cervical surface.

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Exclusion Criteria

1. the tooth was scheduled to be restored by placing a crown, telescopic crown or bridge anchor at first detection of CCL,
2. the tooth was scheduled to be extracted at first detection of CCL.
3. the cervical root caries lesions was detected on a wisdom tooth
4. extension of the caries to the occlusal surface.

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Addresses

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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Mr.  Dr.  Richard  Wierichs 
    • Pauwelsstr. 30,
    • 52074  Aachen
    • Germany
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Mr.  Dr.  Richard  Wierichs 
    • Pauwelsstr. 30,
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.