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

NCT05684601 | Completed DMC

• 1 other identifier: 65-22-PO
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Third Molar Surgery; Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Visual analogue Scale (VAS), values 1-10

  Evaluation of VAS value changes at baseline and follow-up session

  1- and 3-months

Study Arms (2)

rotating drills device

PLACEBO COMPARATOR

Third molar surgery performed with traditional rotating devices

Device: Third molar surgery

Piezoelectric device

ACTIVE COMPARATOR

Third molar surgery performed with piezoelectric surgery device

Device: Third molar surgery

Interventions

Third molar surgery DEVICE

It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device

Piezoelectric device; rotating drills device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Treatment performed with sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 13, 2023
• Study Start: September 15, 2020
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1-year
• Access Criteria: Publication on pubmed

Locations

IT (1)