Impacted Third Molar ToothNCT03619460
Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction
A study testing piezoelectric extraction and conventional extraction in people with Impacted Third Molar Tooth, run by Azienda Ospedaliera di Bolzano at 1 site in Italy.
Trial summary
the aim of this randomized controlled clinical study is to evaluate the efficacy of a new piezoelectric technique for wisdom teeth extraction without using manual tools versus the conventional one.Patients referred to the hospital of Bolzano for wisdom tooth extraction will be randomly divided in two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- piezoelectric extraction and conventional extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to 1 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred for wisdom tooth extraction
- Patients older than 18 years old and able to sign the informed consent
Who cannot join
- General contraindications to surgery.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- Patients who took or are taking bisphosphonates intravenously.
- Uncontrolled diabetes
- Presence of oral pathologies that seriously involved oral mucosa
Show all 14Show fewer
- Patients with poor oral hygiene and motivation.
- Patients with oral pathologies with serious mucosal involvement
- Pregnancy or lactation.
- Addiction to alcohol or drugs.
- Psychiatric problems.
- Patients with an acute infection inflammation around the tooth to be extracted.
- Wisdom teeth with roots attached or positioned around the nerve
- Patients unable to come to the required follow up visits
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Bolzano Hospital
Bolzano, 39100
FABRIZIO FONTANELLA, MDS, +39471908408, FABRIZIO.FONTANELLA@ASBZ.IT
About this study
Official title: Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction Without Using Manual Tools: a Clinical Randomized Controlled Study.
the aim of this randomized controlled clinical study is to evaluate the efficacy of a new piezoelectric technique for wisdom teeth extraction without using manual tools versus the conventional one.Patients referred to the hospital of Bolzano for wisdom tooth extraction will be randomly divided in two groups. In the test group all the procedure will be performed using piezoelectric instruments, while in the control one conventional manual instruments will be used. Main outcome measures are patient pain and complications, secondary outcome measures are duration of the surgical treatment and soft tissue healing
Read the detailed description
Wisdom teeth extraction can be difficult and patient can suffer post operative swelling and pain. A new piezoelectric technique for wisdom teeth extraction was developed and it showed promising results in terms of surgical effectiveness and patients post operative complications. The aim of the study is to compare the new technique with special designed piezoelectric tools with the traditional one in a randomized controlled way. The same procedures are to be followed for teeth extraction except for the use of a piezoelectric lever in one group and a manual lever in the other one. The study is a mono-center, pragmatic, randomised clinical trial (RCT) of parallel group design. The trial would have one week follow up. All patients referred to the Dental Department of S.Maurizio Hospital (Bolzano, Italy) for the extraction of wisdom teeth are considered eligible for the study.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- piezoelectric extraction, conventional extraction
- Keywords
- wisdom teeth, extraction, piezoelectric technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezoelectric extractionProcedure or surgery
Only Piezoelectric device will be used for surgical wisdom teeth extraction
conventional extractionProcedure or surgery
Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction
| Study group | Role | What they receive |
|---|---|---|
| piezoelectric extraction | Experimental | The flap will be raised using a Piezoelectric elevator, the eventual bone around the third molar crown will be removed with the same piezoelectric lever used for luxation and root extraction. The eventual rizectomy will be performed using a piezoelectric saw. Receives: Procedure: piezoelectric extraction |
| conventional extraction | Active comparator | The flap will be raised using a manual elevator and the eventual bone around the third molar crown will be removed with a bone bur with a straight handpiece while the eventual rizectomy will be performed using a bone bur. Manual levers will be used for luxation and tooth extraction Receives: Procedure: conventional extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Patient's perception of pain
- a visual analogue scale with categorical value from 0 to 10 will be filled by the patient at 6 hours after surgical treatment and every morning in the following 7 days.
Measured: 7 days
Secondary outcomes (4)
Patient's perception of pain
the number of analgesics taken by the patients will be recorded: the patient will register the number of tablets taken after the surgery up to the 7th day
Measured: 7 days
Duration of the surgical treatment
measured from opening of the flap to end of the extraction, suturing excluded
Measured: 1 day
Complication
Any intrasurgical complication will be registered. Besides swelling and trismus will be evaluated at half an hour, 3 and 7 days after the surgery. Bleeding will be evaluated half an hour after the treatment.
Measured: 7 days
Healing of soft tissues
presence of normal healing, inflammation, suppuration will be recorded
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will take amoxicillin + clavulanic acid and Ibuprofen 600mg . Mepivacain with 1:100.000 adrenalin will be used for anesthesia. Local infiltration of Desamethasone 4mg and intraoral disinfection of the surgical area with povidone iodine will be done. A full thickness flap will be raised after a sulcular incision from the mesial buccal aspect of the second molar to the distal aspect of the third one where a releasing incision begins describing an open V shape. In the Piezoelectric group Piezoelectric tools will be used. In the conventional group manual tools and burs with a straight handpiece will be used. The flap will be sutured using a 3/0 suture. Levobupivacaine hydrochloride 5mg will be injected at the end of the procedure in the site of the operation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grusovin Maria Gabriella, Azienda Ospedaliera di Bolzano
- Investigators
- FABRIZIO FONTANELLA, MDS, Study director, BOLZANO HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619460
- Sponsor's protocol ID
- 0060125-BZ
- Status last verified
- Jan 2019
- First submitted
- 20 Jul 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: CLINICAL STUDY REPORT
Publications
Piersanti L, Dilorenzo M, Monaco G, Marchetti C. Piezosurgery or conventional rotatory instruments for inferior third molar extractions? J Oral Maxillofac Surg. 2014 Sep;72(9):1647-52. doi: 10.1016/j.joms.2014.04.032. Epub 2014 May 6.
PubMed 25109581Vercellotti T Cap. 4 Tecniche di Estrazione dentale pag 31- 47 Piezosurgery elementi essenziali. Ed Quintessenza 2009
Vercellotti T Cap.8 Nuove tecniche estrazioni dentali pag. 185 -255. La chirurgia ossea piezoelettrica: una nuova era. Ed Quintessenza 2016
Barone A, Marconcini S, Giacomelli L, Rispoli L, Calvo JL, Covani U. A randomized clinical evaluation of ultrasound bone surgery versus traditional rotary instruments in lower third molar extraction. J Oral Maxillofac Surg. 2010 Feb;68(2):330-6. doi: 10.1016/j.joms.2009.03.053. Epub 2010 Jan 15.
PubMed 20116704Itro A, Lupo G, Marra A, Carotenuto A, Cocozza E, Filipi M, D'Amato S. The piezoelectric osteotomy technique compared to the one with rotary instruments in the surgery of included third molars. A clinical study. Minerva Stomatol. 2012 Jun;61(6):247-53. English, Spanish.
PubMed 22669054Goyal M, Marya K, Jhamb A, Chawla S, Sonoo PR, Singh V, Aggarwal A. Comparative evaluation of surgical outcome after removal of impacted mandibular third molars using a Piezotome or a conventional handpiece: a prospective study. Br J Oral Maxillofac Surg. 2012 Sep;50(6):556-61. doi: 10.1016/j.bjoms.2011.10.010. Epub 2011 Nov 15.
PubMed 22088359Sortino F, Pedulla E, Masoli V. The piezoelectric and rotatory osteotomy technique in impacted third molar surgery: comparison of postoperative recovery. J Oral Maxillofac Surg. 2008 Dec;66(12):2444-8. doi: 10.1016/j.joms.2008.06.004.
PubMed 19022121Spinato S, Rebaudi A, Bernardello F, Bertoldi C, Zaffe D. Piezosurgical treatment of crestal bone: quantitative comparison of post-extractive socket outcomes with those of traditional treatment. Clin Oral Implants Res. 2016 Mar;27(3):361-6. doi: 10.1111/clr.12555. Epub 2015 Jan 30.
PubMed 25639687Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.
PubMed 15263877
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction Without Using Manual Tools: a Clinical Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03619460
- Acronym / sponsor ID
- 0060125-BZ
- Conditions
- Impacted Third Molar Tooth
- Keywords
- wisdom teeth, extraction, piezoelectric technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di BolzanoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 Aug 2018 (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.
the aim of this randomized controlled clinical study is to evaluate the efficacy of a new piezoelectric technique for wisdom teeth extraction without using manual tools versus the conventional one.Patients referred to the hospital of Bolzano for wisdom tooth extraction will be randomly divided in two groups. In the test group all the procedure will be performed using piezoelectric instruments, while in the control one conventional manual instruments will be used. Main outcome measures are patient pain and complications, secondary outcome measures are duration of the surgical treatment and soft tissue healing
Detailed description
Wisdom teeth extraction can be difficult and patient can suffer post operative swelling and pain. A new piezoelectric technique for wisdom teeth extraction was developed and it showed promising results in terms of surgical effectiveness and patients post operative complications. The aim of the study is to compare the new technique with special designed piezoelectric tools with the traditional one in a randomized controlled way. The same procedures are to be followed for teeth extraction except for the use of a piezoelectric lever in one group and a manual lever in the other one. The study is a mono-center, pragmatic, randomised clinical trial (RCT) of parallel group design. The trial would have one week follow up. All patients referred to the Dental Department of S.Maurizio Hospital (Bolzano, Italy) for the extraction of wisdom teeth are considered eligible for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients will take amoxicillin + clavulanic acid and Ibuprofen 600mg . Mepivacain with 1:100.000 adrenalin will be used for anesthesia. Local infiltration of Desamethasone 4mg and intraoral disinfection of the surgical area with povidone iodine will be done. A full thickness flap will be raised after a sulcular incision from the mesial buccal aspect of the second molar to the distal aspect of the third one where a releasing incision begins describing an open V shape. In the Piezoelectric group Piezoelectric tools will be used. In the conventional group manual tools and burs with a straight handpiece will be used. The flap will be sutured using a 3/0 suture. Levobupivacaine hydrochloride 5mg will be injected at the end of the procedure in the site of the operation
| Arm | Type | Receives |
|---|---|---|
| piezoelectric extraction | Experimental | Procedure: piezoelectric extractionThe flap will be raised using a Piezoelectric elevator, the eventual bone around the third molar crown will be removed with the same piezoelectric lever used for luxation and root extraction. The eventual rizectomy will be performed using a piezoelectric saw. |
| conventional extraction | Active comparator | Procedure: conventional extractionThe flap will be raised using a manual elevator and the eventual bone around the third molar crown will be removed with a bone bur with a straight handpiece while the eventual rizectomy will be performed using a bone bur. Manual levers will be used for luxation and tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for wisdom tooth extraction
- Patients older than 18 years old and able to sign the informed consent
Key exclusion criteria (14 listed)
- General contraindications to surgery.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- Patients who took or are taking bisphosphonates intravenously.
- Uncontrolled diabetes
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 extractionOnly Piezoelectric device will be used for surgical wisdom teeth extraction | Procedure or surgery | piezoelectric extraction |
| conventional extractionOnly manual instruments and burs on straight handpick will be used for wisdom teeth extraction | Procedure or surgery | conventional extraction |
Primary outcome
Subjective Patient's perception of pain
Time frame: 7 days
- a visual analogue scale with categorical value from 0 to 10 will be filled by the patient at 6 hours after surgical treatment and every morning in the following 7 days.
4 secondary outcomes
Patient's perception of pain
Time frame: 7 days
Duration of the surgical treatment
Time frame: 1 day
Complication
Time frame: 7 days
Healing of soft tissues
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Background: PubMed 25109581Piersanti L, Dilorenzo M, Monaco G, Marchetti C. Piezosurgery or conventional rotatory instruments for inferior third molar extractions? J Oral Maxillofac Surg. 2014 Sep;72(9):1647-52. doi: 10.1016/j.joms.2014.04.032. Epub 2014 May 6.
- BackgroundVercellotti T Cap. 4 Tecniche di Estrazione dentale pag 31- 47 Piezosurgery elementi essenziali. Ed Quintessenza 2009
- BackgroundVercellotti T Cap.8 Nuove tecniche estrazioni dentali pag. 185 -255. La chirurgia ossea piezoelettrica: una nuova era. Ed Quintessenza 2016
- Results publication: PubMed 20116704Barone A, Marconcini S, Giacomelli L, Rispoli L, Calvo JL, Covani U. A randomized clinical evaluation of ultrasound bone surgery versus traditional rotary instruments in lower third molar extraction. J Oral Maxillofac Surg. 2010 Feb;68(2):330-6. doi: 10.1016/j.joms.2009.03.053. Epub 2010 Jan 15.
- Results publication: PubMed 22669054Itro A, Lupo G, Marra A, Carotenuto A, Cocozza E, Filipi M, D'Amato S. The piezoelectric osteotomy technique compared to the one with rotary instruments in the surgery of included third molars. A clinical study. Minerva Stomatol. 2012 Jun;61(6):247-53. English, Spanish.
- Results publication: PubMed 22088359Goyal M, Marya K, Jhamb A, Chawla S, Sonoo PR, Singh V, Aggarwal A. Comparative evaluation of surgical outcome after removal of impacted mandibular third molars using a Piezotome or a conventional handpiece: a prospective study. Br J Oral Maxillofac Surg. 2012 Sep;50(6):556-61. doi: 10.1016/j.bjoms.2011.10.010. Epub 2011 Nov 15.
- Results publication: PubMed 19022121Sortino F, Pedulla E, Masoli V. The piezoelectric and rotatory osteotomy technique in impacted third molar surgery: comparison of postoperative recovery. J Oral Maxillofac Surg. 2008 Dec;66(12):2444-8. doi: 10.1016/j.joms.2008.06.004.
- Results publication: PubMed 25639687Spinato S, Rebaudi A, Bernardello F, Bertoldi C, Zaffe D. Piezosurgical treatment of crestal bone: quantitative comparison of post-extractive socket outcomes with those of traditional treatment. Clin Oral Implants Res. 2016 Mar;27(3):361-6. doi: 10.1111/clr.12555. Epub 2015 Jan 30.
- Results publication: PubMed 15263877Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.
- Individual participant dataSharing planned: Undecided. CLINICAL STUDY REPORT
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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.
FABRIZIO FONTANELLA, MDS study director
BOLZANO HOSPITAL
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 extraction and conventional extraction in people with Impacted Third Molar Tooth, run by Azienda Ospedaliera di Bolzano 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 2 inclusion and 14 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 11 Jan 2019. 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 MARIA GABRIELLA GRUSOVIN, DDS (+39 3482250966, GABRI.GRUSOVIN@TISCALI.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Patient's perception of pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619460, which also lists 9 linked publications.
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 11 Jan 2019.