Impacted Third Molar Tooth
Conditions
Keywords
wisdom teeth, extraction, piezoelectric technique
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.
Interventions
PROCEDUREpiezoelectric extraction
Only Piezoelectric device will be used for surgical wisdom teeth extraction
PROCEDUREconventional extraction
Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction
Sponsors
Azienda Ospedaliera di Bolzano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Healing of soft tissues | 7 days | presence of normal healing, inflammation, suppuration will be recorded |
Countries
Italy
Contacts
Primary ContactMARIA GABRIELLA GRUSOVIN, DDS
Backup ContactTOMASO VERCELLOTTI, MDS
Outcome results
None listed