Third Molar SurgeryNCT05684601
Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery
A study testing Third molar surgery in people with Third Molar Surgery and Impacted Third Molar Tooth, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Molar Surgery, Impacted Third Molar Tooth
- What is being tested?
- Third molar surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2020to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery Using Piezosurgery Versus Traditional Rotating Instrumentations
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.
Read the 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.
- Conditions
- Third Molar Surgery, Impacted Third Molar Tooth
- Being tested
- Third molar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgeryDevice
It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device
| Study group | Role | What they receive |
|---|---|---|
| rotating drills device | Placebo comparator | Third molar surgery performed with traditional rotating devices Receives: Device: Third molar surgery |
| Piezoelectric device | Active comparator | Third molar surgery performed with piezoelectric surgery device Receives: Device: Third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue Scale (VAS), values 1-10
Evaluation of VAS value changes at baseline and follow-up session
Measured: 1- and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Sep 2020
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684601
- Sponsor's protocol ID
- 65-22-PO
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery Using Piezosurgery Versus Traditional Rotating Instrumentations
- ClinicalTrials.gov ID
- NCT05684601
- Acronym / sponsor ID
- 65-22-PO
- Conditions
- Third Molar Surgery, Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| rotating drills device | Placebo comparator | Device: Third molar surgeryThird molar surgery performed with traditional rotating devices |
| Piezoelectric device | Active comparator | Device: Third molar surgeryThird molar surgery performed with piezoelectric surgery device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third molar surgeryIt was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device | Device | Piezoelectric device, rotating drills device |
Primary outcome
Visual analogue Scale (VAS), values 1-10
Time frame: 1- and 3-months
Evaluation of VAS value changes at baseline and follow-up session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Yes. Study protocol
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A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar surgery in people with Third Molar Surgery and Impacted Third Molar Tooth, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue Scale (VAS), values 1-10 (time frame: 1- and 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.