A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone

Официальное название

A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Piezoelectric syndesmotomy
  Syndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.

Первичные конечные точки

• Mean difference of bone sounding (mm) before and after tooth extraction [Срок оценки: Day0, before and after the surgical extraction]

Вторичные конечные точки (5)

• Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21 [Срок оценки: 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 [Срок оценки: Day 1, 3, 7, 21 after tooth extraction]
• Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21 [Срок оценки: 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 [Срок оценки: Day 1, 3, 7, 21 after tooth extraction]
• Number of analgesics taken a week after the surgical procedure [Срок оценки: From surgical procedure to day 7]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A.Gemelli IRCCS — Rome

Идентификаторы

NCT: NCT06612684 · 6139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗