Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery

Impacted Third Molar Tooth Clinical Trial

Official title:

Analysis Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery Using Piezosurgery Versus Traditional Rotating Instrumentations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684601
• Other study ID #: 65-22-PO
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: October 20, 2022

Study information

• Verified date: January 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Third Molar Surgery
• Tooth, Impacted

Intervention

Device:
• Third molar surgery
It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue Scale (VAS), values 1-10	Evaluation of VAS value changes at baseline and follow-up session	1- and 3-months