Trial document




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  DRKS00016888

Trial Description

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Title

ReversFix Technology: Non-destructive removal of orthodontic brackets and dental restorations

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Trial Acronym

ReversFix

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URL of the Trial

https://www.uniklinik-ulm.de/zahnaerztliche-prothetik/studien.html

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Brief Summary in Lay Language

Probands with a vital tooth which has to be extracted but which does not show acute symptoms, who meet the further inclusion and no exclusion criteria, will be included in the ReversFix Study. A bracket (“fixed brace”; substudy 1), a veneer (ceramic shell, substudy 2) or a crown (substudy 3) is bonded to the study tooth which has to be extracted. At the next study appointment, the bracket or restoration (veneer/ crown) is removed conventionally in the control group or with the ReversFix Technology (removal by laser light) in the intervention group. The tooth is extracted one week later (end of study).
The aim of the study is the detection of traumatic changes in the dental nerve in vital study teeth after Bracket-/ Veneer-/ Crown-Removal in histological cuts. Besides, the frequency and intensity of physical complaints is documented. We classify the risk for pain caused by the removal by laser light as very low due to a very low temperature rise inside the teeth in our laboratory studies, which is harmless according to current evidence. Besides, a comparison of the tooth surface’s 3D-data and a health economic analysis will be performed and the number of laser pulses until removal succeeds will be documented for the intervention group. The restorations will be investigated for microdestructions in the intervention group.
The inclusion criteria are as follows: legally competent women and men between 18 and 80 years of age with at least one vital tooth, which has to be extracted and which has to fulfill the following criteria:
- Without acute symptoms
- sufficient intact enamel quantity (enamel: outermost dental layer) at the vestibular (visible when laughing) surface (bracket substudy)
- finishing line has to be exclusively located in the enamel after preparation (preparation for veneers vestibularly, orally or if necessary approximately (different surfaces of a tooth)) (veneer substudy)
- teeth which can be prepared to receive a crown (crown substudy)
- intact, unharmed gingiva or shielded gingiva around the therapeutical target area
- presence of informed consent

The exclusion criteria are as follows:
-pregnancy/ breast feeding
- infectious diseases (viral Hepatitis and HIV)
-alcohol and drug abuse
-teeth with highly divergent roots on the X-ray, which have to be separated prior to extraction
- teeth with a Molar-Incisor-Hypomineralization
- teeth with an Amelogenesis imperfecta
- teeth with a Dentinogenesis imperfecta
-Turner Teeth
- Dependent people (employees of the Center of Dentistry, Department of Prosthetic Dentistry, Ulm University and dental students of Ulm University)
- accessibility of study tooth not given for laser treatment

The duration of study is approximately 2 weeks in substudy 1 (brackets) and approximately 3 weeks in substudy 2 (veneers) and 3 (crowns), respectively, from submission of informed consent to the end of study. There is no difference concerning the duration of study between the intervention and the control group.

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Brief Summary in Scientific Language

Probands with a vital tooth, which has to be extracted but which does not show acute symptoms, who meet the further inclusion and no exclusion criteria, will be included in the clinical, uni-center, open phase-II ReversFix Study. A bracket (“fixed brace”; substudy 1), a veneer (ceramic shell, substudy 2) or a crown (substudy 3) is bonded to the tooth which has to be extracted. Twenty probands are planned for each substudy. The recruiting for the substudies will be risk adapted according to the given order (first substudy 1, followed by substudy 2, followed by substudy 3). At the next study appointment, the bracket or restoration (veneer/ crown) is removed conventionally in the control group or with the ReversFix Technology (removal by laser light) in the intervention group. The tooth is extracted one week later (end of study).
Primary outcome of the study is the detection of traumatic changes in the pulp in vital study teeth after Bracket-/ Veneer-/ Crown-Removal in histological cuts:
The secondary Outcomes of the study are:
- frequency and intensity of physical complaints as documented using a self-reported visual analog scale (VAS)
- comparison of the tooth surface’s 3D-data
-health economic analysis
-number of laser pulses until removal succeeds (intervention group)
- Analysis of the restorations for microdestructions (intervention group; substudy 2 and 3)

The inclusion criteria are as follows: legally competent women and men between 18 and 80 years of age with at least one vital tooth, which has to be extracted and which has to fulfill the following criteria:
- Without acute symptoms
-sufficient intact enamel quantity at the vestibular surface (bracket substudy)
- finishing line has to be exclusively located in the enamel after preparation (preparation for veneers vestibularly, orally or if necessary approximately) (veneer substudy)
- teeth which can be prepared to receive a crown (crown substudy)
- intact, unharmed gingiva or shielded gingiva around the therapeutical target area
- presence of informed consent

The exclusion criteria are as follows:
- pregnancy/ breast feeding
- infectious diseases (viral Hepatitis and HIV)
- alcohol and drug abuse
- teeth with highly divergent roots on the X-ray, which have to be separated prior to extraction
- teeth with a Molar-Incisor-Hypomineralization
- teeth with an Amelogenesis imperfecta
- teeth with a Dentinogenesis imperfecta
- Turner Teeth
- Dependent people (employees of the Center of Dentistry, Department of Prosthetic Dentistry, Ulm University and dental students of Ulm University)
- accessibility of study tooth not given for laser treatment

The duration of study is planned to be 2 years including recruiting. For the proband, the duration of study is approximately 2 weeks in substudy 1 (brackets) and approximately 3 weeks in substudy 2 (veneers) and 3 (crowns), respectively, from submission of informed consent to the end of study. There is no difference concerning the duration of study between the intervention and the control group.
This is a uni-center, prospective, randomized, open, clinical phase-II pilot study (RCT) with small number of cases. It is classified as investigator-initiated, non-profit trial (IIT) according to MPG.

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Organizational Data

  •   DRKS00016888
  •   2019/03/13
  •   [---]*
  •   yes
  •   Approved
  •   144/16, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   CIV-16-04-015244 
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Health Condition or Problem studied

  •   K02 -  Dental caries
  •   K07 -  Dentofacial anomalies [including malocclusion]
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Interventions/Observational Groups

  •   Intervention Group: Removal of a bracket (substudy 1), veneer (substudy 2) or crown (substudy 3), which has been bonded to a vital tooth without acute symptoms, which has to be extracted, using the CE-certified dermatological laser system (Er:YAG laser) MCL31 Dermablate with laser handpiece MCL29 with distance holder (Asclepion Laser Technologies GmbH).
  •   Control Group: Conventional removal of bracket (substudy 1), veneer (substudy 2) or crown (substudy 3), which has been bonded to a vital tooth without acute symptoms, which has to be extracted, using a plier (bracket) or a bur in combination with crown removal instruments to detach the restoration (veneer, crown).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Primary Outcome of substudy 1 (Brackets), 2 (Veneers) and 3 (Crowns): Traumatic changes in the pulp in vital study teeth after Bracket-/ Veneer-/ Crown-Removal in histological cuts:
We are searching for signs of a thermal trauma in the histological cuts according to the signs of a thermal trauma identified in animal studies. These are histiocytes, fragments of odontoblasts’ nuclei, aspirated odontblasts’ nuclei, vacuoles between the odontoblasts, locally reduced predentine’s thickness and hyperemic changes. In case of further histologically noticeable cells and structures, these will be investigated as well in the phase-II pilot study. In case of signs of a thermal trauma, these will be quantified using histomorphometric methods. If applicable, areas of the pulp which are far away from the exposure site of the bur and the laser, respectively, will be investigated as well for comparison with the pulp area directly at the exposure site. The primary outcome is collected for each proband after his/her end of study after tooth extraction.

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Secondary Outcome

Secondary Outcomes of substudy 1 (Brackets), 2 (Veneers) and 3 (Crowns):
- frequency and intensity of physical complaints as documented using a self-reported visual analog scale (VAS)**
- comparison of the tooth surface’s 3D-data*
- health economic analysis**
- number of laser pulses until removal succeeds (intervention group)*
- Analysis of the restorations for microdestructions (intervention group; substudy 2 and 3)*
The secondary outcomes are collected for each proband after the removal of the bracket/veneer, crown for the outcomes marked with * and after his/her end of study for the outcomes marked with **.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/03/22
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

The inclusion criteria are as follows: legally competent women and men between 18 and 80 years of age with at least one vital tooth, which has to be extracted and which has to fulfill the following criteria:
- Without acute symptoms
- sufficient intact enamel quantity at the vestibular surface (bracket substudy)
- finishing line has to be exclusively located in the enamel after preparation (preparation for veneers vestibularly, orally or if necessary approximately) (veneer substudy)
- teeth which can be prepared to receive a crown (crown substudy)
- intact, unharmed gingiva or shielded gingiva around the therapeutical target area
- presence of informed consent

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Exclusion Criteria

The exclusion criteria are as follows:
- pregnancy/ breast feeding
- infectious diseases (viral Hepatitis and HIV)
- alcohol and drug abuse
- teeth with highly divergent roots on the X-ray, which have to be separated prior to extraction
- teeth with a Molar-Incisor-Hypomineralization
- teeth with an Amelogenesis imperfecta
- teeth with a Dentinogenesis imperfecta
- Turner Teeth
-Dependent people (employees of the Center of Dentistry, Department of Prosthetic Dentistry, Ulm University and dental students of Ulm University)
- accessibility of study tooth not given for laser treatment

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Addresses

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    • Universitätsklinikum Ulm
    • 89081  Ulm
    • Germany
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    • Klinik für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.   Ralph G.  Luthardt 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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    • Klinik für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.  Ralph G.  Luthardt 
    • Albert-Einstein-Allee 11
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für Zahn- Mund und Kieferheilkunde (DGZMK)
    • Liesegangstraße 17a
    • 40211  Düsseldorf
    • Germany
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    •   [---]*
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    • Asclepion Laser Technologies GmbH
    • 07747  Jena
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Bundesministerium für Bildung und Forschung (BMBF): Unterstützung Vorversuche und Studienbeantragung (Finanzierung zeitlich vor anderen Finanzierungsquellen abgeschlossen)
    • 10117   Berlin
    • Germany
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Status

  •   Recruiting planned
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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.