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

NCT ID: NCT05684601

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Third Molar Surgery Impacted Third Molar Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Treatment performed with sealed envelopes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rotating drills device

Third molar surgery performed with traditional rotating devices

Group Type PLACEBO_COMPARATOR

Third molar surgery

Intervention Type DEVICE

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

Piezoelectric device

Third molar surgery performed with piezoelectric surgery device

Group Type ACTIVE_COMPARATOR

Third molar surgery

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Third molar surgery

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Catania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Policlinico G. Rodolico

Catania, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

65-22-PO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phytotherapy Agent in Third Molar Surgery
NCT03335683 COMPLETED PHASE4