Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

NCT04915443 | Completed DMC

• 1 other identifier: EA/m-2019-3013
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Extraction; Dental Implant

Keywords

Extraction; Implant; Periotome; Piezotome; Atraumatic

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Periotome Group

EXPERIMENTAL

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

Piezotome Group

EXPERIMENTAL

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

Interventions

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.

Periotome Group

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.

Piezotome Group

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Qassim Unversity Dental Clinics

Buraidah, Saudi Arabia

Location

Related Publications (5)

• 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.

  PMID: 30294165 BACKGROUND

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

  PMID: 11819949 BACKGROUND

• 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.

  PMID: 26225052 BACKGROUND

• 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.

  PMID: 28713729 BACKGROUND

• 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.

  PMID: 24661578 BACKGROUND

Study Officials

• DAYASHANKARA JK RAO, MDS,MFDSRCS

  College of Dentistry Qassim University, Kingdom of Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 7, 2021
• Study Start: December 2, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

SA (1)