Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction
January 9, 2019 updated by: Grusovin Maria Gabriella, Azienda Ospedaliera di Bolzano
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bolzano, Italy, 39100
- Recruiting
- Bolzano Hospital
-
Contact:
- FABRIZIO FONTANELLA, MDS
- Phone Number: +39471908408
- Email: FABRIZIO.FONTANELLA@ASBZ.IT
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients referred for wisdom tooth extraction
- Patients older than 18 years old and able to sign the informed consent
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: piezoelectric extraction
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.
|
Only Piezoelectric device will be used for surgical wisdom teeth extraction
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ACTIVE_COMPARATOR: conventional extraction
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
|
Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's perception of pain
Time Frame: 7 days
|
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
|
7 days
|
|
Duration of the surgical treatment
Time Frame: 1 day
|
measured from opening of the flap to end of the extraction, suturing excluded
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1 day
|
|
Complication
Time Frame: 7 days
|
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.
|
7 days
|
|
Healing of soft tissues
Time Frame: 7 days
|
presence of normal healing, inflammation, suppuration will be recorded
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: FABRIZIO FONTANELLA, MDS, Bolzano Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Vercellotti 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. Erratum In: J Oral Maxillofac Surg. 2018 Apr 28;:
- Itro 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.
- Goyal 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.
- Sortino 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.
- Spinato 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.
- Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2018
Primary Completion (ANTICIPATED)
March 1, 2019
Study Completion (ANTICIPATED)
March 1, 2019
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
August 2, 2018
First Posted (ACTUAL)
August 8, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0060125-BZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
CLINICAL STUDY REPORT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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