Trial document





This trial has been registered retrospectively.
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  DRKS00004701

Trial Description

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Title

Cost-effectiveness analysis of tooth maintenance vs. implant therapy for deeply destroyed teeth: A multicenter, prospective, randomized pilot trial

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Trial Acronym

CoAT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The present study focuses on the treatment of a deeply destroyed anterior tooth or premolar. There are two therapy options: 1. The deeply destroyed tooth has to be reconstructed and needs a root canal treatment. After that it will have to be restored (e.g. with a crown). In order to ensure sufficient crown retention it will be necessary to remove parts of the bone surrounding the tooth and the proximate teeth (a so called surgical crown lengthening). 2. The deeply destroyed tooth has to be removed. The lesion has to heel for about 8 weeks .Then the bone will be measured (clinical diagnostics) and an artificial root of a tooth (Implant) will be inserted. About 3 months later an artificial tooth crown (restoration) will be fixed on the implant.
The success of the restoration shall be inspected during the period of five years. For the root canal treatment as well as for the implantation x-ray images are necessary. In addition to the cost-effectiveness analysis of the two kinds of treatments, the study aims at the comparison of the clinical success of crowns that are fixed either on a deeply destroyed tooth with a root canal treatment or on an implant.

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Brief Summary in Scientific Language

Aim of the present study is a cost-effectiveness/ cost-benefit analysis of two treatment approaches for deeply destroyed teeth with neighboring teeth without treatment need. Tooth maintenance (TM) will be compared to implant therapy (IT). The null hypothesis is that there is no difference in the cost-effectiveness ratio between the two treatment approaches applying the effectiveness parameters success, survival, aesthetics and quality of life (cost-utility analysis).

The study is designed as a multicenter, prospective randomized trial and piggy-back time recording, costing and cost-effectiveness analysis. The primary outcome measure is success (without technical or biological treatment need, only maintenance care), secondary outcome measures are survival (restoration/ tooth/ implant still in function), aesthetics (score), and quality of life (sum, progression).

Forty subjects with treatment need for one deeply destroyed front tooth or premolar with a mesial-distal extension ≥ 7 mm will be included. Twenty subjects each are recruited in two centers (University Ulm, Private practice Stahnsdorf).

The tooth maintenance will need (post-) endodontic treatment and surgical crown lengthening. Implants are placed 6-8 weeks after tooth removal. In both groups single all-ceramic crowns will be placed. The patients will be followed over 5 years.

A preleminary analysis will be performed after treating the first 4 patients. In case of necessary changes to the study protocol it will be modified. The number of patients included in the study will then rise form 40 to 44.

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Organizational Data

  •   DRKS00004701
  •   2013/02/20
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  •   yes
  •   Approved
  •   48/11, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   K08.81 -  [generalization K08.8: Other specified disorders of teeth and supporting structures]
  •   K02.5
  •   S02.5 -  Fracture of tooth
  •   K02.1 -  Caries of dentine
  •   K02.2 -  Caries of cementum
  •   K02.9 -  Dental caries, unspecified
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Interventions/Observational Groups

  •   The deeply destroyed tooth has to be reconstructed and needs a root canal treatment. After that it will have to be restored (e.g. with a crown). In order to ensure sufficient crown retention it will be necessary to remove parts of the bone surrounding the tooth and the proximate teeth (a so called surgical crown lengthening)
  •   The deeply destroyed tooth has to be removed. The lesion has to heel for about 8 weeks .Then the bone will be measured (clinical diagnostics) and an artificial root of a tooth (Implant) will be inserted. About 3 months later an artificial tooth crown (restoration) will be fixed on the implant.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Health economics
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Success without technical or biological treatment need after 5 years, Cost-effectiveness analysis

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Secondary Outcome

Tooth or implant loss (yes/no)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/11/15
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Subjects with the treatment need for one deeply destroyed front tooth or premolar with a proximal distance ≥ 7 mm will be included. Decoronated teeth with a supra-gingival amount of hard tissue after crown preparation of less than 2 mm in height will be receiving a surgical crown lengthening in order to ensure sufficient retention.

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Exclusion Criteria

Minors or persons incapable of contracting; pregnant women; alcohol or drug addicts; patients with an existing infectious disease as hepatitis or HIV/AIDS; patients where an existing general disease means a contraindication for an implantation; patients with a severe diabetes; patients with a periodontally harmed abutment tooth (degree of tooth mobility > 1 and/or a pocket depth > 3.5 mm); patients with insufficient oral hygiene (PI > 1, BOP positive on more than 20% of all teeth);patients, who would be in a conflict of interests due to their participation in another study; patients, who did participate in another clinical study within one month prior to the beginning of the study.

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Addresses

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    • Universitätsklinik Ulm
    • Mr.  Prof. Dr. med. dent.  Ralph G.  Luthardt (PI) 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Dr. Kießling & Prof. Dr. Naumann Zahnärzte an der Kleinmachnower Schleuse
    • Mr.  Prof. Dr.  Miachael  Naumann (Stellv. PI) 
    • Wannseestraße. 42
    • 14532  Stahnsdorf
    • Germany
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    • Universitätsklinik Ulm, Klinik für Zahnärztliche Prothetik
    • Ms.  Dr.  Heike  Rudolph 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik
    • Ms.  Dr.  Heike  Rudolph 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Ulm
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • ITI Foundation, ITI Center
    • Peter-Merian-Weg 10
    • 4052  Basel
    • Switzerland
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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.