About this trial
In both surgical and nor surgical tooth extractions, the first phase is done by syndesmotomy. This procedure allows to interrupt the fibers of the periodontal ligament. Traditionally, syndesmotomy is done by manual instruments. Usually, the manual approach leads to the loss of the vestibular cortical plate due to the size of those instruments.
The piezoelectric surgery device provides an alternative to manual instruments. Its advantages are: selectivity for hard tissues; better cut control; protection of soft tissue, vessels and nerves; post-op pain and discomfort reduction.
The aim of this study is to evaluate a piezosurgery driven syndesmotomy technique during tooth extraction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
has mobility grade 0 or 1
is considered hopeless or needs to be extracted due to orthodontic indication
Sign of informed consent
Disqualifiers
Age lower than 18 years old
Pregnancy
Heavy smokers (more than 10 cigarettes a day)
Uncompensated systemic diseases
Trial design
Single group
Treatments tested in this trial
Piezoelectric syndesmotomy
DeviceSyndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.
Treatment groups
Trial outcomes
Primary outcomes
Mean difference of bone sounding (mm) before and after tooth extraction
Bone sounding is a measurement in millimeters that represents the distance between alveolar crest and free gingival margin. This measurement is taken under local anesthesia before and after the tooth extraction. This outcome provides informations about the integrity of the alveolar bone before and after the surgical procedure. Six sites for tooth are considered. The mean difference expressed in millimeters is considered for each site.
Secondary outcomes
Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21
The Visual Analog Scale (VAS SCALE - score 0-10) is submitted to the patient after tooth extraction to evaluate the post-operative pain and discomfort in four different times after the surgical procedure.
Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21
The Visual Analog Scale (VAS SCALE - score 0-10) is submitted to the patient after tooth extraction to evaluate the post-operative pain and discomfort in four different times after the surgical procedure. The trend of VAS value at each time is observed
Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21
The Quality of Life score (QoL score - score 0-100) is submitted to the patient after tooth extraction to evaluate the post-operative quality of life in four different times after the surgical procedure.
Post-operative quality of life trend evaluation: QoL score differences (0-100) at D1, D3, D7 and D21
The Quality of Life score (QoL score - score 0-100) is submitted to the patient after tooth extraction to evaluate the post-operative quality of life in four different times after the surgical procedure. The trend of QoL value at each time is observed
Sponsors and contacts
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