NCT02495207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

June 19, 2015

Last Update Submit

July 26, 2017

Conditions

Third Molars Extraction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of viable bone cells

    This variable will be measured from the specimens taken within the first 15 minutes of bone cutting to remove third molars

Study Arms (2)

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.

Device: Piezosurgery

Interventions

PiezosurgeryDEVICE

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

Piezosurgery

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Damascus, Damscus, DM20AM18, Syria

Location

Related Publications (5)

  • 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.

    PMID: 21419542BACKGROUND

  • 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.

    PMID: 25234524BACKGROUND

  • 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.

    PMID: 22890087BACKGROUND

  • 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.

    PMID: 23196065BACKGROUND

  • 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.

    PMID: 23916119BACKGROUND

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmad Al-buzem, DDS

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 13, 2015

Study Start

June 1, 2014

Primary Completion

March 14, 2016

Study Completion

April 14, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)