Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

Study Overview
=================
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.

Official Title
-----------------
Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

Conditions
-----------------
Dental Extraction, Dental Implant

Intervention / Treatment
-----------------
* Device: Periotome
* Device: Piezotome


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periotome Group<br>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. | Device: Periotome<br>* 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.<br>|
| Experimental: Piezotome Group<br>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. | Device: Piezotome<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extraction, Implant, Periotome, Piezotome, Atraumatic