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

Not Applicable

Not yet recruiting

• Conditions: Tooth Extraction; Piezoelectric Technique
• Interventions: Device: Piezoelectric syndesmotomy

• Registration Number: NCT06612684
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Piezoelectric syndesmotomy of single-rooted teeth	Piezoelectric syndesmotomy	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.

Primary Outcome Measures

Name	Time	Method
Mean difference of bone sounding (mm) before and after tooth extraction	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21	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.
Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21	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
Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21	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.
Post-operative quality of life trend evaluation: QoL score differences (0-100) at D1, D3, D7 and D21	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
Number of analgesics taken a week after the surgical procedure	From surgical procedure to day 7	It is asked to each patient how many analgesics he needed after the surgical procedure

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Rome, Italy