Third Molars ExtractionNCT02495207
A Comparison Between Conventional Surgery and Piezosurgery
A study testing Piezosurgery in people with Third Molars Extraction, run by Damascus University at 1 site in Syria.
Trial summary
Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal of impacted mandibular third molars on both sides of the jaw. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Third Molars Extraction
- What is being tested?
- Piezosurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSyria
- Study dates
- Jun 2014to 14 Apr 2017
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- bilateral identical impacted third molar that need at least 3 mm of bone removal
Who cannot join
- Pregnancy
- Smokers
- Infectious diseases
- Infections around third molars (i.e. pericoronitis).
- Alcoholic patients
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
Damascus, Damscus, DM20AM18
About this study
Official title: A Histo-immunological Comparative Study of Bone Cutting by Conventional Surgery and Piezosurgery on the Secretion of Heat Shock Protein 70 (HSP70) and on the Bone Cells
Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal of impacted mandibular third molars on both sides of the jaw.
Read the detailed description
The study is about measuring the amount of HSP70 using Elisa kit for detecting HSP70 and mason trichrome for histological findings in which the study samples are patients who have bilateral impacted mandibular third molar to be extracted with bone removal. First we collect bone sample for mason trichrome with either method then we collect the second samples after removing most of the bones cover the impacted third molar for checking HSP70 levels. Then the bone samples are treated using a special protocol to eliminate the protein from bone samples for the Elisa analysis. The other bone samples are going to be studied under the microscope.
- Conditions
- Third Molars Extraction
- Being tested
- Piezosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezosurgeryDevice
This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgery | No intervention | No intervention in this arm. The patients are going to undergo normal surgical intervention. Conventional surgery will be performed to extract the impacted third molars. |
| Piezosurgery | Experimental | Patients here will undergo a piezosurgery to extract their third molars on both sides. Receives: Device: Piezosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Heat Shock Protein 70
This will be measured using ELISA methodology
Measured: Five minutes before third molar removal with the last removed layer of bone
Secondary outcomes (1)
Percentage of viable bone cells
Percentage of viable bone cells will be calculated based on the counts of viable bone cells observed under the microscope.
Measured: This variable will be measured from the specimens taken within the first 15 minutes of bone cutting to remove third molars
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2014
- Primary completion14 Mar 2016
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Third Molars ExtractionStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad Al-buzem, DDS, Principal investigator, MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495207
- Sponsor's protocol ID
- UDDS-OMFS-03-2015
- Status last verified
- Jul 2017
- First submitted
- 19 Jun 2015
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sivolella S, Berengo M, Bressan E, Di Fiore A, Stellini E. Osteotomy for lower third molar germectomy: randomized prospective crossover clinical study comparing piezosurgery and conventional rotatory osteotomy. J Oral Maxillofac Surg. 2011 Jun;69(6):e15-23. doi: 10.1016/j.joms.2010.12.036. Epub 2011 Mar 21.
PubMed 21419542Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.
PubMed 25234524Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.
PubMed 22890087Gulnahar Y, Huseyin Kosger H, Tutar Y. A comparison of piezosurgery and conventional surgery by heat shock protein 70 expression. Int J Oral Maxillofac Surg. 2013 Apr;42(4):508-10. doi: 10.1016/j.ijom.2012.10.027. Epub 2012 Nov 26.
PubMed 23196065Gulnahar Y, Kosger HH, Tutar Y. The role of preoperative oxidative stress and mandibular third molar postoperative outcome--reply. Int J Oral Maxillofac Surg. 2013 Nov;42(11):1500-1. doi: 10.1016/j.ijom.2013.07.002. Epub 2013 Aug 1. No abstract available.
PubMed 23916119
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histo-immunological Comparative Study of Bone Cutting by Conventional Surgery and Piezosurgery on the Secretion of Heat Shock Protein 70 (HSP70) and on the Bone Cells
- ClinicalTrials.gov ID
- NCT02495207
- Acronym / sponsor ID
- UDDS-OMFS-03-2015
- Conditions
- Third Molars Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 14 Mar 2016 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 13 Jul 2015 (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.
Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal of impacted mandibular third molars on both sides of the jaw.
Detailed description
The study is about measuring the amount of HSP70 using Elisa kit for detecting HSP70 and mason trichrome for histological findings in which the study samples are patients who have bilateral impacted mandibular third molar to be extracted with bone removal. First we collect bone sample for mason trichrome with either method then we collect the second samples after removing most of the bones cover the impacted third molar for checking HSP70 levels. Then the bone samples are treated using a special protocol to eliminate the protein from bone samples for the Elisa analysis. The other bone samples are going to be studied under the microscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgery | No intervention | –No intervention in this arm. The patients are going to undergo normal surgical intervention. Conventional surgery will be performed to extract the impacted third molars. |
| Piezosurgery | Experimental | Device: PiezosurgeryPatients here will undergo a piezosurgery to extract their third molars on both sides. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- bilateral identical impacted third molar that need at least 3 mm of bone removal
Key exclusion criteria (5 listed)
- Pregnancy
- Smokers
- Infectious diseases
- Infections around third molars (i.e. pericoronitis).
- Alcoholic patients
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 |
|---|---|---|
| PiezosurgeryThis intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars. | Device | Piezosurgery |
Primary outcome
Levels of Heat Shock Protein 70
Time frame: Five minutes before third molar removal with the last removed layer of bone
This will be measured using ELISA methodology
1 secondary outcome
Percentage of viable bone cells
Time frame: This variable will be measured from the specimens taken within the first 15 minutes of bone cutting to remove third molars
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 27 Jul 2017.
- Background: PubMed 21419542Sivolella S, Berengo M, Bressan E, Di Fiore A, Stellini E. Osteotomy for lower third molar germectomy: randomized prospective crossover clinical study comparing piezosurgery and conventional rotatory osteotomy. J Oral Maxillofac Surg. 2011 Jun;69(6):e15-23. doi: 10.1016/j.joms.2010.12.036. Epub 2011 Mar 21.
- Background: PubMed 25234524Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.
- Background: PubMed 22890087Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.
- Background: PubMed 23196065Gulnahar Y, Huseyin Kosger H, Tutar Y. A comparison of piezosurgery and conventional surgery by heat shock protein 70 expression. Int J Oral Maxillofac Surg. 2013 Apr;42(4):508-10. doi: 10.1016/j.ijom.2012.10.027. Epub 2012 Nov 26.
- Background: PubMed 23916119Gulnahar Y, Kosger HH, Tutar Y. The role of preoperative oxidative stress and mandibular third molar postoperative outcome--reply. Int J Oral Maxillofac Surg. 2013 Nov;42(11):1500-1. doi: 10.1016/j.ijom.2013.07.002. Epub 2013 Aug 1. No abstract available.
- 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.
Ahmad Al-buzem, DDS principal investigator
MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery in people with Third Molars Extraction, run by Damascus University at 1 site in Syria.
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 5 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 27 Jul 2017. 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 Syria. 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?
Levels of Heat Shock Protein 70 (time frame: Five minutes before third molar removal with the last removed layer of bone). 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 NCT02495207, which also lists 5 linked publications.
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 27 Jul 2017.