A Comparison Between Conventional Surgery and Piezosurgery

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.

Study Overview

• Status: Completed
• Conditions: Third Molars Extraction
• Intervention / Treatment: Device: Piezosurgery

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damscus
    • Damascus, Damscus, Syrian Arab Republic, DM20AM18
      • Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Surgery; 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.
Experimental: Piezosurgery; Patients here will undergo a piezosurgery to extract their third molars on both sides.	Device: Piezosurgery; This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of Heat Shock Protein 70	This will be measured using ELISA methodology	Five minutes before third molar removal with the last removed layer of bone

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This variable will be measured from the specimens taken within the first 15 minutes of bone cutting to remove third molars

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Ahmad Al-buzem, DDS, MSc student, Oral and Maxillofacial Department, University of Damascus Dental School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): March 14, 2016
• Study Completion (Actual): April 14, 2017

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-OMFS-03-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO