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NCT Number: NCT06612684

A New Syndesmotomy Technique for Tooth Extractions to Preserve 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Location contact

Paolo Francesco Manicone, Associate professor

CONTACT

[email protected]

+390630155701

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piezoelectric syndesmotomy

Device

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

Primary outcomes

  1. Mean difference of bone sounding (mm) before and after tooth extraction

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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

  5. Number of analgesics taken a week after the surgical procedure

    Time frame: From surgical procedure to day 7

    It is asked to each patient how many analgesics he needed after the surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Francesco Manicone, Principal investigator

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SINDESM-EXt

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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