Clinical trial NCT02495207: A Comparison Between Conventional Surgery and Piezosurgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Molars Extraction
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* bilateral identical impacted third molar that need at least 3 mm of bone removal

Exclusion Criteria:

* Pregnancy
* Smokers
* Infectious diseases
* Infections around third molars (i.e. pericoronitis).
* Alcoholic patients

Primary outcomes:
measure: Levels of Heat Shock Protein 70
timeFrame: Five minutes before third molar removal with the last removed layer of bone
Secondary outcomes:
measure: Percentage of viable bone cells
timeFrame: This variable will be measured from the specimens taken within the first 15 minutes of bone cutting to remove third molars
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
state: Damscus
Study officials:
affiliation: MSc student, Oral and Maxillofacial Department, University of Damascus Dental School
name: Ahmad Al-buzem, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mantovani 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.
citation: Rullo 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.
citation: Gulnahar 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.
citation: Gulnahar 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.