Tooth ExtractionSINDESM-EXtNCT06612684
A New Syndesmotomy Technique for Tooth Extractions to Preserve the Alveolar Bone
A study testing Piezoelectric syndesmotomy in people with Tooth Extraction and Piezoelectric Technique, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Piezoelectric Technique
- What is being tested?
- Piezoelectric syndesmotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Paolo Francesco Manicone, Principal investigator contact
Italy1 site
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, Rome, 00168
Paolo Francesco Manicone, Associate professor, +390630155701, paolofrancesco.manicone@unicatt.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Extraction, Piezoelectric Technique
- Being tested
- Piezoelectric syndesmotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric syndesmotomyDevice
Syndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Piezoelectric syndesmotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From surgical procedure to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manicone Paolo Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- PAOLO FRANCESCO MANICONE, Associate professor, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612684
- Sponsor's protocol ID
- 6139
- Acronym
- SINDESM-EXt
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone
- ClinicalTrials.gov ID
- NCT06612684
- Acronym / sponsor ID
- SINDESM-EXt / 6139
- Conditions
- Tooth Extraction, Piezoelectric Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric syndesmotomy of single-rooted teeth | Experimental | Device: Piezoelectric syndesmotomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezoelectric syndesmotomySyndesmotomy, the first phase of tooth extraction, will be provided by a piezoelectric device instead of manual instruments. | Device | Piezoelectric syndesmotomy of single-rooted teeth |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
Number of analgesics taken a week after the surgical procedure
Time frame: From surgical procedure to day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Francesco Manicone, Principal investigator contact
PAOLO FRANCESCO MANICONE, Associate professor principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezoelectric syndesmotomy in people with Tooth Extraction and Piezoelectric Technique, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Francesco Manicone, Principal investigator (+390630155701, paolofrancesco.manicone@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of bone sounding (mm) before and after tooth extraction (time frame: Day0, before and after the surgical extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.