Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

NCT03619460 | Unknown DMC

• 1 other identifier: 0060125-BZ
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Impacted Third Molar Tooth

Keywords

wisdom teeth; extraction; piezoelectric technique

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (4)

• Patient's perception of pain

  7 days

• Duration of the surgical treatment

  1 day

• Complication

  7 days

• Healing of soft tissues

  7 days

Study Arms (2)

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.

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

Procedure: conventional extraction

Interventions

piezoelectric extraction PROCEDURE

Only Piezoelectric device will be used for surgical wisdom teeth extraction

piezoelectric extraction

conventional extraction PROCEDURE

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

conventional extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for wisdom tooth extraction
• Patients older than 18 years old and able to sign the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Bolzano: lead

Study Sites (1)

Bolzano Hospital

Bolzano, 39100, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 25109581 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 20116704 RESULT

• 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.

  PMID: 22669054 RESULT

• 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.

  PMID: 22088359 RESULT

• 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.

  PMID: 19022121 RESULT

• 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.

  PMID: 25639687 RESULT

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

  PMID: 15263877 RESULT

Study Officials

• FABRIZIO FONTANELLA, MDS

  BOLZANO HOSPITAL

  STUDY DIRECTOR

Central Study Contacts

MARIA GABRIELLA GRUSOVIN, DDS

CONTACT

+39 3482250966; GABRI.GRUSOVIN@TISCALI.IT

TOMASO VERCELLOTTI, MDS

CONTACT

+39 335382085; TOMASO@VERCELLOTTI.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 8, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

IT (1)