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Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

Primary Purpose

Impacted Third Molar Tooth

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

piezoelectric extraction

conventional extraction

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring wisdom teeth, extraction, piezoelectric technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Bolzano HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

piezoelectric extraction

conventional extraction

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Duration of the surgical treatment

measured from opening of the flap to end of the extraction, suturing excluded

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.

Healing of soft tissues

presence of normal healing, inflammation, suppuration will be recorded

Full Information

NCT ID

NCT03619460

First Posted

July 20, 2018

Last Updated

January 9, 2019

Sponsor

Azienda Ospedaliera di Bolzano

1. Study Identification

Unique Protocol Identification Number

NCT03619460

Brief Title

Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

Official Title

Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction Without Using Manual Tools: a Clinical Randomized Controlled Study.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

March 1, 2019 (Anticipated)

Study Completion Date

March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera di Bolzano

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impacted Third Molar Tooth

Keywords

wisdom teeth, extraction, piezoelectric technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

piezoelectric extraction

Arm Type

Experimental

Arm Description

Arm Title

conventional extraction

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

piezoelectric extraction

Intervention Description

Only Piezoelectric device will be used for surgical wisdom teeth extraction

Intervention Type

Procedure

Intervention Name(s)

conventional extraction

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective Patient's perception of pain

Description

- 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.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Patient's perception of pain

Description

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

Time Frame

7 days

Title

Duration of the surgical treatment

Description

measured from opening of the flap to end of the extraction, suturing excluded

Time Frame

1 day

Title

Complication

Description

Time Frame

7 days

Title

Healing of soft tissues

Description

presence of normal healing, inflammation, suppuration will be recorded

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MARIA GABRIELLA GRUSOVIN, DDS

Phone

+39 3482250966

GABRI.GRUSOVIN@TISCALI.IT

First Name & Middle Initial & Last Name or Official Title & Degree

TOMASO VERCELLOTTI, MDS

Phone

+39 335382085

TOMASO@VERCELLOTTI.COM

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

FABRIZIO FONTANELLA, MDS

Organizational Affiliation

BOLZANO HOSPITAL

Official's Role

Study Director

Facility Information:

Facility Name

Bolzano Hospital

City

Bolzano

ZIP/Postal Code

39100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

FABRIZIO FONTANELLA, MDS

Phone

+39471908408

FABRIZIO.FONTANELLA@ASBZ.IT

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

CLINICAL STUDY REPORT

Citations:

PubMed Identifier

25109581

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

20116704

Citation

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;:

Results Reference

result

PubMed Identifier

22669054

Citation

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.

Results Reference

result

PubMed Identifier

22088359

Citation

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.

Results Reference

result

PubMed Identifier

19022121

Citation

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.

Results Reference

result

PubMed Identifier

25639687

Citation

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.

Results Reference

result

PubMed Identifier

15263877

Citation

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

Results Reference

result

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Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

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