Periotome Versus Peizotome as an Aid of Atraumatic Extraction. (RCT)

June 7, 2021 updated by: Mohammed Alraqibah, Qassim University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Buraidah, Saudi Arabia
        • Qassim Unversity Dental Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periotome Group
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

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.
Experimental: Piezotome Group
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Duration
Time Frame: 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).
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
Time Frame: 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).
At the end of the extraction procedure up to 60 minutes
Operative Pain
Time Frame: 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)
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
Time Frame: 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)
8 hours following the Procedure tell the 7th day.
Analgesics Intake
Time Frame: 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.
8 hours following the intervention tell the 7th day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qassim University

Investigators

  • Study Director: DAYASHANKARA JK RAO, MDS,MFDSRCS, College of Dentistry Qassim University, Kingdom of Saudi Arabia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Actual)

March 16, 2021

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EA/m-2019-3013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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