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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

has mobility grade 0 or 1

is considered hopeless or needs to be extracted due to orthodontic indication

Sign of informed consent

Disqualifiers

Age lower than 18 years old

Pregnancy

Heavy smokers (more than 10 cigarettes a day)

Uncompensated systemic diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Piezoelectric syndesmotomy

    Device

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Piezoelectric syndesmotomy of single-rooted teethExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day0, before and after the surgical extraction

Secondary outcomes

1

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.

Time frame
Day 1, 3, 7, 21 after tooth extraction
2

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

Time frame
Day 1, 3, 7, 21 after tooth extraction
3

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.

Time frame
Day 1, 3, 7, 21 after tooth extraction
4

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

Time frame
Day 1, 3, 7, 21 after tooth extraction

Other outcomes

Sponsors and contacts

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