Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

NCT ID: NCT03619460

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-03-01

Brief Summary

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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

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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

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sequentially sealed opaque envelopes will be opened by a nurse not involved in the treatment of the patient and a number will be assigned to the patients included in the study. The randomization code will be disclosed at the end of the statistical analysis. The doctor who will evaluate the complications, the duration of the procedure and the healing will be not aware of the type of treatment provided to the patients, nor will be the patients.

Study Groups

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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.

Group Type EXPERIMENTAL

piezoelectric extraction

Intervention Type PROCEDURE

Only Piezoelectric device will be used for surgical wisdom teeth extraction

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

Group Type ACTIVE_COMPARATOR

conventional extraction

Intervention Type PROCEDURE

Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction

Interventions

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piezoelectric extraction

Only Piezoelectric device will be used for surgical wisdom teeth extraction

Intervention Type PROCEDURE

conventional extraction

Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliera di Bolzano

OTHER

Sponsor Role lead

Responsible Party

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Grusovin Maria Gabriella

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FABRIZIO FONTANELLA, MDS

Role: STUDY_DIRECTOR

BOLZANO HOSPITAL

Locations

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Bolzano Hospital

Bolzano, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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MARIA GABRIELLA GRUSOVIN, DDS

Role: CONTACT

+39 3482250966

TOMASO VERCELLOTTI, MDS

Role: CONTACT

+39 335382085

Facility Contacts

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FABRIZIO FONTANELLA, MDS

Role: primary

+39471908408

References

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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.

Reference Type BACKGROUND
PMID: 25109581 (View on PubMed)

Vercellotti T Cap. 4 Tecniche di Estrazione dentale pag 31- 47 Piezosurgery elementi essenziali. Ed Quintessenza 2009

Reference Type BACKGROUND

Vercellotti T Cap.8 Nuove tecniche estrazioni dentali pag. 185 -255. La chirurgia ossea piezoelettrica: una nuova era. Ed Quintessenza 2016

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 20116704 (View on PubMed)

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.

Reference Type RESULT
PMID: 22669054 (View on PubMed)

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.

Reference Type RESULT
PMID: 22088359 (View on PubMed)

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.

Reference Type RESULT
PMID: 19022121 (View on PubMed)

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.

Reference Type RESULT
PMID: 25639687 (View on PubMed)

Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.

Reference Type RESULT
PMID: 15263877 (View on PubMed)

Other Identifiers

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0060125-BZ

Identifier Type: -

Identifier Source: org_study_id

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