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

Sponsor

University of Catania (Other)

Overall Status

Completed

CT.gov ID

NCT05684601

Collaborator

(none)

Enrollment

Location

Arms

25.1

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Third Molar Surgery Impacted Third Molar Tooth	Device: Third molar surgery	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Participant, Care Provider)

Masking Description:

Treatment performed with sealed envelopes

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2020

Actual Primary Completion Date :

Oct 20, 2022

Actual Study Completion Date :

Oct 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: rotating drills device Third molar surgery performed with traditional rotating devices	Device: Third molar surgery It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device
Active Comparator: Piezoelectric device Third molar surgery performed with piezoelectric surgery device	Device: Third molar surgery It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device

Arm

Intervention/Treatment

Placebo Comparator: rotating drills device

Third molar surgery performed with traditional rotating devices

Device: Third molar surgery

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

Active Comparator: Piezoelectric device

Third molar surgery performed with piezoelectric surgery device

Device: Third molar surgery

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

Outcome Measures

Primary Outcome Measures

Visual analogue Scale (VAS), values 1-10 [1- and 3-months]
Evaluation of VAS value changes at baseline and follow-up session

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

Principal Investigator: Gaetano Isola, University of Catania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Researcher, University of Catania

ClinicalTrials.gov Identifier:

NCT05684601

Other Study ID Numbers:

65-22-PO

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth, Impacted

Study Results

No Results Posted as of Jan 13, 2023