Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

Not Applicable

• Conditions: Impacted Third Molar Tooth
• Interventions: Procedure: piezoelectric extraction; Procedure: conventional extraction

• Registration Number: NCT03619460
• Lead Sponsor: Azienda Ospedaliera di Bolzano

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.

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Study Start: 2018-10-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piezoelectric extraction	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.
conventional 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

Primary Outcome Measures

Name	Time	Method
Subjective Patient's perception of pain	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.

Secondary Outcome Measures

Name	Time	Method
Complication	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.
Patient's perception of pain	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
Duration of the surgical treatment	1 day	measured from opening of the flap to end of the extraction, suturing excluded
Healing of soft tissues	7 days	presence of normal healing, inflammation, suppuration will be recorded

Trial Locations

Locations (1)

Bolzano Hospital; 🇮🇹 Bolzano, Italy