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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Extraction; Piezoelectric Technique
• Intervention / Treatment: Device: Piezoelectric syndesmotomy

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Francesco Manicone, Principal investigator; Phone Number: +390630155701; Email: paolofrancesco.manicone@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario A.Gemelli IRCCS
    • Contact: Paolo Francesco Manicone, Associate professor; Phone Number: +390630155701; Email: paolofrancesco.manicone@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezoelectric syndesmotomy of single-rooted teeth; 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.	Device: Piezoelectric syndesmotomy; Syndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of bone sounding (mm) before and after tooth 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.	Day0, before and after the surgical extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21	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.	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	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	Day 1, 3, 7, 21 after tooth extraction
Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21	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.	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	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	Day 1, 3, 7, 21 after tooth extraction
Number of analgesics taken a week after the surgical procedure	It is asked to each patient how many analgesics he needed after the surgical procedure	From surgical procedure to day 7

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: PAOLO FRANCESCO MANICONE, Associate professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 6139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No