A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone (SINDESM-EXt)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Tooth Extraction; Piezoelectric Technique

Treatments: Device: Piezoelectric syndesmotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06612684

6139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Piezoelectric syndesmotomy of single-rooted teeth

Experimental group

Description:

Patients who need the extraction of a single-rooted hopeless tooth will be included in the intervention arm. The extraction of the tooth will be executed by piezoelectric syndesmotomy and by the use of forceps.

Treatment:

Device: Piezoelectric syndesmotomy