A Comparison Between Conventional Surgery and Piezosurgery

NCT ID: NCT02495207

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-04-14

Brief Summary

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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

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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

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Third Molars Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Piezosurgery

Patients here will undergo a piezosurgery to extract their third molars on both sides.

Group Type EXPERIMENTAL

Piezosurgery

Intervention Type DEVICE

This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.

Interventions

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Piezosurgery

This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmad Al-buzem, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student, Oral and Maxillofacial Department, University of Damascus Dental School

Locations

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Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Damascus, Damscus, Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 21419542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25234524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22890087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23196065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23916119 (View on PubMed)

Other Identifiers

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UDDS-OMFS-03-2015

Identifier Type: -

Identifier Source: org_study_id

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