Frank Falkensammer1,2, Wolfgang Schaden3, Christoph Krall4, Josef Freudenthaler5, Hans-Peter Bantleon5. 1. Bernhard Gottlieb University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria. frank.falkensammer@meduniwien.ac.at. 2. Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090, Vienna, Austria. frank.falkensammer@meduniwien.ac.at. 3. AUVA-Trauma Center Meidling, Vienna, Austria. 4. Institute of Medical Statistics, Medical University of Vienna, Vienna, Austria. 5. Bernhard Gottlieb University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.
Abstract
OBJECTIVES: The effect of non-invasive extracorporeal shockwaves on pulpal blood flow in orthodontic patients who have undergone active treatment was investigated. MATERIALS AND METHODS:Seventy-two adult patients were enrolled in the clinical trial and allocated by block randomization to a treatment or a placebo group at a 1:1 ratio. The patients were required to be otherwise healthy. Blinding was performed for the subjects and the outcome assessor. The region of interest was the mandibular incisors and canines, which were vital, unrestored, and had experienced no trauma. The active treatment group received a single shockwave treatment with 1000 impulses at 0.19-0.23 mJ/mm(2) while the placebo group was treated with a deactivated shockwave applicator but acoustic sham. Pulpal blood flow was evaluated four times over a period of 6 months starting from the day of bracket removal, using a laser Doppler device. RESULTS:Thirty patients were evaluated in each group. Orthodontic patients who have undergone active treatment tend to have high levels of pulpal blood flow which decrease over a period of 6 months. Pulpal blood flow did not differ significantly over 6 months between the placebo and treatment group. Shockwave treatment was associated with no significant effect in respect of tooth type, age, sex, or mean blood pressure, and had no unintended pernicious effects. CONCLUSIONS: Extracorporeal shockwaves had no statistically significant effect on pulpal blood flow. Multiple applications of ESWT in a pathological setup may be needed in future studies to demonstrate significant differences. CLINICAL RELEVANCE: The absence of any adverse effects justifies further principal investigations of the use of shockwave treatment in the oral cavity.
RCT Entities:
OBJECTIVES: The effect of non-invasive extracorporeal shockwaves on pulpal blood flow in orthodontic patients who have undergone active treatment was investigated. MATERIALS AND METHODS: Seventy-two adult patients were enrolled in the clinical trial and allocated by block randomization to a treatment or a placebo group at a 1:1 ratio. The patients were required to be otherwise healthy. Blinding was performed for the subjects and the outcome assessor. The region of interest was the mandibular incisors and canines, which were vital, unrestored, and had experienced no trauma. The active treatment group received a single shockwave treatment with 1000 impulses at 0.19-0.23 mJ/mm(2) while the placebo group was treated with a deactivated shockwave applicator but acoustic sham. Pulpal blood flow was evaluated four times over a period of 6 months starting from the day of bracket removal, using a laser Doppler device. RESULTS: Thirty patients were evaluated in each group. Orthodontic patients who have undergone active treatment tend to have high levels of pulpal blood flow which decrease over a period of 6 months. Pulpal blood flow did not differ significantly over 6 months between the placebo and treatment group. Shockwave treatment was associated with no significant effect in respect of tooth type, age, sex, or mean blood pressure, and had no unintended pernicious effects. CONCLUSIONS: Extracorporeal shockwaves had no statistically significant effect on pulpal blood flow. Multiple applications of ESWT in a pathological setup may be needed in future studies to demonstrate significant differences. CLINICAL RELEVANCE: The absence of any adverse effects justifies further principal investigations of the use of shockwave treatment in the oral cavity.
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