Impact of 3D Intraoral Scanning on Postsurgical Evaluatio... | NCT05684601

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

NCT05684601

Sponsor

University of Catania

Status

Completed

Last Update Posted

Jan 13, 2023Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Third Molar Surgery
Impacted Third Molar Tooth

Interventions

Third molar surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Oct 20, 2022Actual

Completion Date

Oct 20, 2022Actual

First Submitted Date

Dec 26, 2022

First Submission Date that Met QC Criteria

Jan 11, 2023

First Posted Date

Jan 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2023

Last Update Posted Date

Jan 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gaetano Isola	University of Catania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico G. Rodolico		Catania		95124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol

Types

Study Protocol

Time Frame

1-year

Access Criteria

Publication on pubmed

URL

Not provided

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.