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Dental ExtractionRCTNCT04915443

Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

A study testing Periotome and Piezotome in people with Dental Extraction and Dental Implant, run by Qassim University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for
Dental Extraction, Dental Implant
What is being tested?
Periotome and Piezotome
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSaudi Arabia
Study dates
2 Dec 2019to 16 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 62 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Qassim Unversity Dental Clinics

    Buraidah

Other trials in Saudi Arabia

About this study

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.

Read the 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.

Being tested
Periotome, Piezotome
Keywords
Extraction, Implant, Periotome, Piezotome, Atraumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PeriotomeDevice

    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.

  • PiezotomeDevice

    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.

Study groups in NCT04915443
Study groupRoleWhat they receive
Periotome GroupExperimentalAn 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.
Receives: Device: Periotome
Piezotome GroupExperimentalAn 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.
Receives: Device: Piezotome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative Duration

    To compare the operative duration of simple extraction between "Periotome" and "Piezotome" in (minutes).

    Measured: From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes

  2. 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).

    Measured: At the end of the extraction procedure up to 60 minutes

  3. 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)

    Measured: From the beginning of extraction tell the delivery of the tooth out from the socket. From the beginning of intervention up to 60 minutes

  4. 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)

    Measured: 8 hours following the Procedure tell the 7th day.

  5. 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.

    Measured: 8 hours following the intervention tell the 7th day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start2 Dec 2019
  3. Primary completion16 Mar 2021
  4. Study completion16 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915443
Sponsor's protocol ID
EA/m-2019-3013
Acronym
RCT
Status last verified
Jun 2021
First submitted
26 May 2021
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30294165

  • Malden N. Surgical forceps techniques. Dent Update. 2001 Jan-Feb;28(1):41-4. doi: 10.12968/denu.2001.28.1.41.

    PubMed 11819949

  • 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.

    PubMed 26225052

  • 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.

    PubMed 28713729

  • 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.

    PubMed 24661578

Questions about this trial

What is this clinical trial studying?

A study testing Periotome and Piezotome in people with Dental Extraction and Dental Implant, run by Qassim University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04915443, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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