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

Primary Purpose

Third Molar Surgery, Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Third molar surgery
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Third Molar Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AOU Policlinico G. Rodolico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

rotating drills device

Piezoelectric device

Arm Description

Third molar surgery performed with traditional rotating devices

Third molar surgery performed with piezoelectric surgery device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
January 11, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05684601
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Molar Surgery, Impacted Third Molar Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
Treatment performed with sealed envelopes
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rotating drills device
Arm Type
Placebo Comparator
Arm Description
Third molar surgery performed with traditional rotating devices
Arm Title
Piezoelectric device
Arm Type
Active Comparator
Arm Description
Third molar surgery performed with piezoelectric surgery device
Intervention Type
Device
Intervention Name(s)
Third molar surgery
Intervention Description
It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device
Primary Outcome Measure Information:
Title
Visual analogue Scale (VAS), values 1-10
Description
Evaluation of VAS value changes at baseline and follow-up session
Time Frame
1- and 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol
IPD Sharing Time Frame
1-year
IPD Sharing Access Criteria
Publication on pubmed

Learn more about this trial

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

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