Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

Not Applicable

Completed

• Conditions: Dental Extraction; Dental Implant
• Interventions: Device: Piezotome; Device: Periotome

• Registration Number: NCT04915443
• Lead Sponsor: Qassim University

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.

Study Timeline

• Study Start: 2019-12-02
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-31
• Status Verified: 2021-06
• Study First Posted: 2021-06-07
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piezotome Group	Piezotome	An Atraumatic simple extraction procedure is done to teeth or roots with sound form indicated for simple extraction using SOLO LED PIEZOTOME Kit with ESSENTIAL tips from SATELEC ACTEON.
Periotome Group	Periotome	An Atraumatic simple extraction procedure is done to teeth or roots with sound form indicated for simple extraction using H.ZEPF 26.182.13 \& 26.182.11 periotome instrument.

Primary Outcome Measures

Name	Time	Method
Operative Duration	From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes	To compare the operative duration of simple extraction between "Periotome" and "Piezotome" in (minutes).
Gingival Laceration	At the end of the extraction procedure up to 60 minutes	To identify the presence or absence of gingival laceration in the extraction area Immediately after the completion of the extraction procedures (yes/no).
Analgesics Intake	8 hours following the intervention tell the 7th day.	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.
Operative Pain	From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes	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)
Post-Operative Pain	8 hours following the Procedure tell the 7th day.	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)

Trial Locations

Locations (1)

Qassim Unversity Dental Clinics; 🇸🇦 Buraidah, Saudi Arabia