Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

Dental Implant Clinical Trial

— RCT  

Official title:

Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915443
• Other study ID #: EA/m-2019-3013
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: June 2021
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare between periotome and piezotome in terms of efficiency and durability in procedures of simple extractions as an alternative atraumatic extraction technique.

Description:

Teeth extraction is one of the commonly preformed procedures in the dental clinics, and one of the most important precautions followed during the different techniques of teeth extraction is tissue preservation and the avoidance of tissue trauma. So, for the preservation of bone and tissues integrity and elimination of post operative pain and discomfort, atraumatic extraction techniques are presented.

A claim has risen that due to its thin tips which is inserted vertically to the PDL avoiding the leveraging forces caused by conventional elevators, Periotome will aid in the reduction of soft tissue injury and the preservation of bone integrity. While Piezotome which is a newer and innovative device using ultrasonic vibrations mainly for the purpose of osteotomy is considered very efficient due to its selective cutting and being inert against soft tissues, including nerves and blood vessels. leading to lesser cell necrosis and faster bone regeneration providing a minimally invasive atraumatic extraction technique.

And with the rapid development of implantology and painless dentistry, the demands on more efficient, minimally invasive and more durable atraumatic extraction techniques has increased.

This study aims to compare between periotome and piezotome in terms of efficiency and durability in procedures of simple extractions as an alternative atraumatic extraction technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

• Grade I or II patients according to ASA

• Teeth indicated for simple extraction

• Teeth indicated for extraction and immediate implant placement

• Teeth of grade 0-I Mobility

• Remaining roots with sound form

Exclusion Criteria:

• Grade III-VI patients according to ASA

• Mobility Grade = II

• Teeth indicated for surgical extraction

• ASA: American Society of Anesthesiologists Physical Status Classification System 2020

Related Conditions & MeSH terms

• Dental Extraction
• Dental Implant

Intervention

Device:
• Periotome
Dental instrument used to perform atraumatic dental extraction. After the initial de attachment, the periotome was inserted between the root and the bone parallel to the long axis of the root and pushed apically to the maximum depth that the tissue allowes severing the PDL and leaving it for 10-15 seconds allowing the biomechanical creep to occur. This proses is repeated at different points of entries at all the different surfaces of the tooth.
• Piezotome
Dental device used for many purposes one of which is performing atraumatic dental extraction. An LC2 tip was used for all the procedures and it was inserted between the tooth root and the bone parallel to the long axis of the root and moved in a sweeping motion 3-4mm toward the apex severing the PDL.

Locations

Country	Name	City	State
Saudi Arabia	Qassim Unversity Dental Clinics	Buraidah

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (5)

Bhati B, Kukreja P, Kumar S, Rathi VC, Singh K, Bansal S. Piezosurgery versus Rotatory Osteotomy in Mandibular Impacted Third Molar Extraction. Ann Maxillofac Surg. 2017 Jan-Jun;7(1):5-10. doi: 10.4103/ams.ams_38_16. — View Citation

Chang HH, Lee MS, Hsu YC, Tsai SJ, Lin CP. Comparison of clinical parameters and environmental noise levels between regular surgery and piezosurgery for extraction of impacted third molars. J Formos Med Assoc. 2015 Oct;114(10):929-35. doi: 10.1016/j.jfma.2014.02.003. Epub 2014 Mar 21. — View Citation

Malden N. Surgical forceps techniques. Dent Update. 2001 Jan-Feb;28(1):41-4. — View Citation

Sharma SD, Vidya B, Alexander M, Deshmukh S. Periotome as an Aid to Atraumatic Extraction: A Comparative Double Blind Randomized Controlled Trial. J Maxillofac Oral Surg. 2015 Sep;14(3):611-5. doi: 10.1007/s12663-014-0723-8. Epub 2014 Nov 8. — View Citation

Srivastava P, Shetty P, Shetty S. Comparison of Surgical Outcome after Impacted Third Molar Surgery Using Piezotome and a Conventional Rotary Handpiece. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S318-S324. doi: 10.4103/ccd.ccd_354_18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Duration	To compare the operative duration of simple extraction between "Periotome" and "Piezotome" in (minutes).	From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes
Primary	Gingival Laceration	To identify the presence or absence of gingival laceration in the extraction area Immediately after the completion of the extraction procedures (yes/no).	At the end of the extraction procedure up to 60 minutes
Primary	Operative Pain	To evaluate operative pain felt by the patient during the two procedures using (visual analogue scale). The patient is asked after the procedure to give a pain score (using visual analogue scale) to evaluate his/her pain during the procedure.; 0= no pain (best outcome) 10= unberable pain (worst outcome)	From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes
Primary	Post-Operative Pain	To evaluate post-operative pain felt by the patient after the two procedures using (visual analogue scale). The patient is asked after the procedure to give a pain score (using visual analogue scale) to evaluate his/her pain following the procedure in the following order: (1st day, 2nd day, 3rd day and 7th day) from the completion of the procedure.; 0= no pain (best outcome) 10= unberable pain (worst outcome)	8 hours following the Procedure tell the 7th day.
Primary	Analgesics Intake	To calculate the dosage (in mg) of analgesics intake by the patient after the two procedures. The patient is asked to record his/her analgesics intake daily by dose and in the first 7 days following the procedure.	8 hours following the intervention tell the 7th day.