Clinical trial NCT06612684: A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone
Official title: A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Extraction
Piezoelectric Technique
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Mean difference of bone sounding (mm) before and after tooth extraction
timeFrame: Day0, before and after the surgical extraction
Secondary outcomes:
measure: Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21
timeFrame: Day 1, 3, 7, 21 after tooth extraction
measure: Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21
timeFrame: Day 1, 3, 7, 21 after tooth extraction
measure: Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21
timeFrame: Day 1, 3, 7, 21 after tooth extraction
measure: Post-operative quality of life trend evaluation: QoL score differences (0-100) at D1, D3, D7 and D21
timeFrame: Day 1, 3, 7, 21 after tooth extraction
measure: Number of analgesics taken a week after the surgical procedure
timeFrame: From surgical procedure to day 7
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: PAOLO FRANCESCO MANICONE, Associate professor
role: PRINCIPAL_INVESTIGATOR
References: