Clinical trial NCT05684601: Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery
Official title: Analysis Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery Using Piezosurgery Versus Traditional Rotating Instrumentations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Molar Surgery
Impacted Third Molar Tooth
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, 1, 2, 5, 7, 10, 14 and 28 days following surgery in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery in 56 subjects. Ni All subjects were randomly allocated to receive one treatment.

Detailed description: The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery. Fifty-six patients who needed surgical extraction of an impacted mandibular third molar were selected for the study. All subjects were randomly allocated to receive one of the following surgical treatments piezoelectric surgery (n = 28), traditional surgery with rotating device (n = 28). The primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at baseline, 1, 2, 5, 7, 10 and 14 and 28 days following surgery. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 32 years;
* good general health;
* the presence of one impacted third molar in the mandible with a class II position, type B impaction;
* absence of pericoronitis or signs of inflammation during the last 30 days. Panoramic radiographs were used to determine tooth position.

Exclusion Criteria:

* the presence of any systemic disease;
* consumption of oral contraceptives or other medications;
* consumption of any immunosuppressive or anti-inflammatory drugs during the 3 months prior to the study;
* status of pregnancy or lactation;
* previous history of excessive drinking;
* allergy to local anesthetic;
* smoking habit.

Primary outcomes:
measure: Visual analogue Scale (VAS), values 1-10
timeFrame: 1- and 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References: