Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, 00168, Italy
NCT Number: NCT06612684
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Rome, 00168, Italy
Piezoelectric bone surgery is a recent and innovative technology, permitting a selective cut of mineralized tissue while sparing soft tissue. Similar to a dental scaler, a high frequency vibration, in the range of 25-35 kHz, is transmitted to a metallic tip. The handpiece of the instrument is equipped with a sterile irrigation system and light-emitting diode (LED) light, which improves visibility and overall safety. Piezoelectric surgery is particularly useful when performing delicate bone procedures such as periodontal or endodontic surgery. It is also indicated when performing more invasive bone surgery such as maxillectomy, mandibulectomy, and condylectomy, where preservation of neurovascular structures is important. Piezoelectric surgery is still employed in tooth extraction of third lower molars. In literature, there are low evidence of the use of piezoelectric surgery for single-rooted tooth extraction.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Syndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.
Time frame: Day0, before and after the surgical 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.
Time frame: Day 1, 3, 7, 21 after tooth extraction
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.
Time frame: Day 1, 3, 7, 21 after tooth extraction
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
Time frame: Day 1, 3, 7, 21 after tooth extraction
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.
Time frame: Day 1, 3, 7, 21 after tooth extraction
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
Time frame: From surgical procedure to day 7
It is asked to each patient how many analgesics he needed after the surgical procedure
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone
Acronym: SINDESM-EXt
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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