A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piezoelectric syndesmotomy.
- Who it may be relevant to
- Registry conditions: Tooth Extraction, Piezoelectric Technique. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone
Overview
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.
Detailed description
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.
Interventions
- Device Piezoelectric syndesmotomy
Syndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.
Primary outcome measures
- Mean difference of bone sounding (mm) before and after tooth extraction [Time frame: Day0, before and after the surgical extraction]
Secondary outcome measures (5)
- Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21 [Time frame: Day 1, 3, 7, 21 after tooth extraction]
- Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21 [Time frame: Day 1, 3, 7, 21 after tooth extraction]
- Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21 [Time frame: Day 1, 3, 7, 21 after tooth extraction]
- Post-operative quality of life trend evaluation: QoL score differences (0-100) at D1, D3, D7 and D21 [Time frame: Day 1, 3, 7, 21 after tooth extraction]
- Number of analgesics taken a week after the surgical procedure [Time frame: From surgical procedure to day 7]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old
- Single-rooted tooth to extract that:
- has mobility grade 0 or 1
- is considered hopeless or needs to be extracted due to orthodontic indication
- Sign of informed consent
Exclusion criteria
- Age lower than 18 years old
- Pregnancy
- Heavy smokers (more than 10 cigarettes a day)
- Uncompensated systemic diseases
- Drugs that influence wound healing (radiotherapy in the last year, bisphosphonates)
- Low compliance due to psychiatric diseases
- Mobility grade 2 or 3
- Refusal of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A.Gemelli IRCCS — Rome
Identifiers
NCT: NCT06612684 · 6139