Trial document




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  DRKS00010003

Trial Description

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Title

Risk factors for failure in the management of cervical caries lesions

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Trial Acronym

-

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URL of the Trial

http://-

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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). Regarding inactive cervical root caries lesions, there is not even scientific data concerning risk factors for re-activation or prophylactic regimes (monitoring only or plus local fluoridation) for secondary and tertiary prevention

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Organizational Data

  •   DRKS00010003
  •   2016/02/09
  •   [---]*
  •   yes
  •   [---]*
  •   [---]*
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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

  •   active cervical (root) caries lesions (aCCL) (restaurative treatment).
    The following data were collected from the patients’ records meeting the inclusion criteria:
    • characteristics of the involved tooth and the dentition including the tooth-localization and restored tooth-surfaces,
    • grade of activity (active / inactive) according to the definitions of Nyvad & Fejerskov (Nyvad and Fejerskov, 1986),
    • number of 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 first restorative intervention (on the cervical surface) - if present - including information such as the type of intervention/restoration (e.g. filling, crown, extraction) and material used,
    • date of second restorative intervention (on the cervical surface) - if present -including information such as the type of intervention/restoration (e.g. filling, crown, extraction) and material used,
    • age and sex,
    • number of regular check-ups during observation period,
    • risk level of caries (taking into account DMFT at a respective age) (Bratthall and Hansel Petersson, 2005; Paris et al., 2013)
  •   inactive cervical (root) caries lesions (iCCL) (monitoring only or plus local fluoridation).
    The following data were collected from the patients’ records meeting the inclusion criteria:
    • characteristics of the involved tooth and the dentition including the tooth-localization and restored tooth-surfaces,
    • grade of activity (active / inactive) according to the definitions of Nyvad & Fejerskov (Nyvad and Fejerskov, 1986),
    • number of 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 first restorative intervention (on the cervical surface) - if present - including information such as the type of intervention/restoration (e.g. filling, crown, extraction) and material used,
    • date of second restorative intervention (on the cervical surface) - if present -including information such as the type of intervention/restoration (e.g. filling, crown, extraction) and material used,
    • age and sex,
    • number of regular check-ups during observation period,
    • risk level of caries (taking into account DMFT at a respective age) (Bratthall and Hansel Petersson, 2005; Paris et al., 2013)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   No
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Primary Outcome

inactive cervical (root) caries lesions: visual-taactile assessment of the survival for restorative treatment after up to 10 years

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
  •   2016/03/01
  •   300
  •   Monocenter 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 1997 and 2014
2.the cervical (root) caries lesion was detected at least 6 months before the last recall visit. 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 located on the cervical surface (class V in case of restoration),
4.the records contained information on the grade of activity (active / inactive).

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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

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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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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/10
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Trial Publications, Results and other Documents

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