K02 K07
Conditions
Interventions
Group 1: 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, usi
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 **. | — |
Countries
Germany
Contacts
Public ContactRalph G. Luthardt
Klinik für Zahnärztliche Prothetik
Outcome results
None listed