Tooth, ImpactedNCT02942108
Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery
A study testing piezo surgery and conventional surgery in people with Tooth, Impacted, run by University of Belgrade at 1 site in Serbia.
Trial summary
The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- piezo surgery and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- Oct 2016to Apr 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- bilaterally symmetrically impacted lower third molars
Who cannot join
- presence of intraoral infection
- chronic orofacial pain
- pregnancy/ lactation
- heavy tobacco smokers
- alcohol/ drug abuse
- allergic reaction to medicaments used
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients
- Conditions
- Tooth, Impacted
- Being tested
- piezo surgery, conventional surgery
- Keywords
- piezolectric surgery, conventional surgery, lower third molars
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezo surgeryProcedure or surgery
conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| healthy, conventional surgery | Active comparator | Surgical bone removal by conventional rotary burs in healthy patients during third molar surgery Receives: Procedure: conventional surgery |
| healthy, piezo surgery | Experimental | Surgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery Receives: Procedure: piezo surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOD activity in alveolar bone specimen
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
Measured: immediately after surgery
VEGF levels in alveolar bone specimen
Measured: immediately after surgery
MMP-9 level in alveolar bone specimen
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2020
- Study completionApr 2020
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 Tooth, ImpactedStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
- Investigators
- Bozidar M Brkovic, DDS,PhD, Principal investigator, School of Dental Medicine, University of BelgradeMilan V Vucetic, PhD student, Principal investigator, School of Dental Medicine, University of BelgradeMarija S Milic, DDS, PhD, Principal investigator, School of Dental Medicine, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942108
- Sponsor's protocol ID
- 36/20
- Status last verified
- Dec 2022
- First submitted
- 20 Oct 2016
- Last updated
- 5 Dec 2022
- Results posted
- No
Publications
Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
PubMed 32712962
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02942108
- Acronym / sponsor ID
- 36/20
- Conditions
- Tooth, Impacted
- Keywords
- piezolectric surgery, conventional surgery, lower third molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 21 Oct 2016 (estimated)
- 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 clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy, conventional surgery | Active comparator | Procedure: conventional surgerySurgical bone removal by conventional rotary burs in healthy patients during third molar surgery |
| healthy, piezo surgery | Experimental | Procedure: piezo surgerySurgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- bilaterally symmetrically impacted lower third molars
Key exclusion criteria (6 listed)
- presence of intraoral infection
- chronic orofacial pain
- pregnancy/ lactation
- heavy tobacco smokers
- alcohol/ drug abuse
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 surgery | Procedure or surgery | healthy, piezo surgery |
| conventional surgery | Procedure or surgery | healthy, conventional surgery |
Primary outcome
SOD activity in alveolar bone specimen
Time frame: immediately after surgery
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
VEGF levels in alveolar bone specimen
Time frame: immediately after surgery
MMP-9 level in alveolar bone specimen
Time frame: immediately after surgery
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 5 Dec 2022.
- Derived from this study: PubMed 32712962Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
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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.
Bozidar M Brkovic, DDS,PhD principal investigator
School of Dental Medicine, University of Belgrade
Milan V Vucetic, PhD student principal investigator
School of Dental Medicine, University of Belgrade
Marija S Milic, DDS, PhD principal investigator
School of Dental Medicine, University of Belgrade
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 surgery and conventional surgery in people with Tooth, Impacted, run by University of Belgrade at 1 site in Serbia.
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 1 inclusion and 6 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 5 Dec 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 Serbia. 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?
SOD activity in alveolar bone specimen (time frame: immediately after surgery). The study lists 3 primary outcomes in all. 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 NCT02942108, 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 5 Dec 2022.