Swelling/ EdemaNCT05488028
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
A study testing Piezo-electric surgery of impacted lower third molars and Rotary bur surgery of impacted lower third molars in people with Swelling/ Edema and Impacted Third Molar Tooth, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Swelling/ Edema, Impacted Third Molar Tooth
- What is being tested?
- Piezo-electric surgery of impacted lower third molars and Rotary bur surgery of impacted lower third molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 30 Apr 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- good general health conditions;
- presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);
Who cannot join
- no clinical evidence of major facial asymmetry;
- use of medication that would influence or alter wound healing;
- temporomandibular joint disorder history;
- smoking
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Hospital Policlinic Gaetano Martino
Messina, Messina (ME), 98124
About this study
Official title: Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial
Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software
- Conditions
- Swelling/ Edema, Impacted Third Molar Tooth
- Being tested
- Piezo-electric surgery of impacted lower third molars, Rotary bur surgery of impacted lower third molars
- Keywords
- piezosurgery, conventional osteotomy, impacted lower third molar, facial scan, 3d rendering
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezo-electric surgery of impacted lower third molarsProcedure or surgery
During lower third molar surgery, osteotomy is performed using piezoelectric instrumentation.
When necessary, tooth sectioning was performed with a high-speed tungsten carbide slit drill under saline irrigation and the tooth removed in single or multiple segments.
Rotary bur surgery of impacted lower third molarsProcedure or surgery
During lower third molar surgery, osteotomy is performed using rotary instruments
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery | Experimental | Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument Receives: Procedure: Piezo-electric surgery of impacted lower third molars |
| Conventional bur | Experimental | Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur Receives: Procedure: Rotary bur surgery of impacted lower third molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial swelling
T0-T1 and T0-T2 scans are opened and superimposed through three reference points:
endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella).
After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Swelling/ EdemaStudies 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
- Split-mouth model
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488028
- Sponsor's protocol ID
- 01-20
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caputo A, Rubino E, Marciano A, Peditto M, Bellocchio AM, Nucera R, Oteri G. Three-dimensional facial swelling evaluation of piezo-electric vs conventional drilling bur surgery of impacted lower third molar: a randomized clinical trial. BMC Oral Health. 2023 Apr 21;23(1):233. doi: 10.1186/s12903-023-02910-6.
PubMed 37085833
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05488028
- Acronym / sponsor ID
- 01-20
- Conditions
- Swelling/ Edema, Impacted Third Molar Tooth
- Keywords
- piezosurgery, conventional osteotomy, impacted lower third molar, facial scan, 3d rendering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Aug 2022 (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.
Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth model
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery | Experimental | Procedure: Piezo-electric surgery of impacted lower third molarsPatients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument |
| Conventional bur | Experimental | Procedure: Rotary bur surgery of impacted lower third molarsPatients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good general health conditions;
- presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);
Key exclusion criteria (4 listed)
- no clinical evidence of major facial asymmetry;
- use of medication that would influence or alter wound healing;
- temporomandibular joint disorder history;
- smoking
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 |
|---|---|---|
| Piezo-electric surgery of impacted lower third molarsDuring lower third molar surgery, osteotomy is performed using piezoelectric instrumentation. When necessary, tooth sectioning was performed with a high-speed tungsten carbide slit drill under saline irrigation and the tooth removed in single or multiple segments. | Procedure or surgery | Piezosurgery |
| Rotary bur surgery of impacted lower third molarsDuring lower third molar surgery, osteotomy is performed using rotary instruments | Procedure or surgery | Conventional bur |
Primary outcome
Facial swelling
Time frame: 7 days
T0-T1 and T0-T2 scans are opened and superimposed through three reference points: endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella). After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.
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 4 Aug 2022.
- Derived from this study: PubMed 37085833Caputo A, Rubino E, Marciano A, Peditto M, Bellocchio AM, Nucera R, Oteri G. Three-dimensional facial swelling evaluation of piezo-electric vs conventional drilling bur surgery of impacted lower third molar: a randomized clinical trial. BMC Oral Health. 2023 Apr 21;23(1):233. doi: 10.1186/s12903-023-02910-6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo-electric surgery of impacted lower third molars and Rotary bur surgery of impacted lower third molars in people with Swelling/ Edema and Impacted Third Molar Tooth, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" 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 2 inclusion and 4 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 4 Aug 2022. 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. 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?
Facial swelling (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488028, which also lists 1 linked publication.
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 4 Aug 2022.