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

NCT06612684 | Not Yet Recruiting

• 1 other identifier: 6139
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction; Piezoelectric Technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21

  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

  Day 1, 3, 7, 21 after tooth extraction

• Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21

  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

  Day 1, 3, 7, 21 after tooth extraction

• Number of analgesics taken a week after the surgical procedure

  From surgical procedure to day 7

Study Arms (1)

Piezoelectric syndesmotomy of single-rooted teeth

EXPERIMENTAL

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

Interventions

Piezoelectric syndesmotomy DEVICE

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

Piezoelectric syndesmotomy of single-rooted teeth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, Rome, 00168, Italy

Location

Study Officials

• PAOLO FRANCESCO MANICONE, Associate professor

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Francesco Manicone, Principal investigator

CONTACT

+390630155701; paolofrancesco.manicone@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)