Clinical trial NCT04915443: Periotome Versus Peizotome as an Aid of Atraumatic Extraction.
Official title: Periotome Versus Peizotome as an Aid of Atraumatic Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Extraction
Dental Implant
Keywords: Extraction
Implant
Periotome
Piezotome
Atraumatic
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients attending Qassim University dental clinics with teeth indicated for simple extraction will be assigned randomly to one of the two study groups either (Periotome Group) or (Piezotome Group) after insuring that they fit the inclusion criteria.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative Duration
timeFrame: From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes
measure: Gingival Laceration
timeFrame: At the end of the extraction procedure up to 60 minutes
measure: Operative Pain
timeFrame: From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes
measure: Post-Operative Pain
timeFrame: 8 hours following the Procedure tell the 7th day.
measure: Analgesics Intake
timeFrame: 8 hours following the intervention tell the 7th day.
Secondary outcomes:
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Qassim Unversity Dental Clinics
Study officials:
affiliation: College of Dentistry Qassim University, Kingdom of Saudi Arabia
name: DAYASHANKARA JK RAO, MDS,MFDSRCS
role: STUDY_DIRECTOR
References:
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.
citation: Malden N. Surgical forceps techniques. Dent Update. 2001 Jan-Feb;28(1):41-4. doi: 10.12968/denu.2001.28.1.41.
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.
citation: 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.
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.