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Completed

NCT Number: NCT04915443

Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

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.

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Key information

Conditions

Dental Extraction Dental Implant

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qassim Unversity Dental Clinics

Buraidah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periotome

Device

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

Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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)

  4. 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)

  5. 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.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Acronym: RCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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