Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619460
• Other study ID #: 0060125-BZ
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliera di Bolzano
• Contact: MARIA GABRIELLA GRUSOVIN, DDS
• Phone: +39 3482250966
• Email: GABRI.GRUSOVIN[@]TISCALI.IT
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• piezoelectric extraction
Only Piezoelectric device will be used for surgical wisdom teeth extraction
• conventional extraction
Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction

Locations

Country	Name	City	State
Italy	Bolzano Hospital	Bolzano

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Bolzano

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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: 10.1 — View 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. — View 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. En — View 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. — View Citation

Sortino F, Pedullà 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. — View 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/c — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	7 days
Secondary	Duration of the surgical treatment	measured from opening of the flap to end of the extraction, suturing excluded	1 day
Secondary	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.	7 days
Secondary	Healing of soft tissues	presence of normal healing, inflammation, suppuration will be recorded	7 days