Clinical trial NCT03619460: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: wisdom teeth
extraction
piezoelectric technique
Lead sponsor: Azienda Ospedaliera di Bolzano
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective Patient's perception of pain
timeFrame: 7 days
Secondary outcomes:
measure: Patient's perception of pain
timeFrame: 7 days
measure: Duration of the surgical treatment
timeFrame: 1 day
measure: Complication
timeFrame: 7 days
measure: Healing of soft tissues
timeFrame: 7 days
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Bolzano Hospital
Study officials:
affiliation: BOLZANO HOSPITAL
name: FABRIZIO FONTANELLA, MDS
role: STUDY_DIRECTOR
References:
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