Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments

NCT06262841 | Completed

• 1 other identifier: Murat Kaan Erdem
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Change in Oral Health-related Quality of Life

  Evaluated by Oral Health Impact Profile-14 questionnaire (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.

  Time Frame: 14 days

Secondary Outcomes (4)

• Change in pain

  7 days

• Change in Mouth opening

  7 days

• Operation time

  Intraoperative

• Change in facial swelling

  7 days

Study Arms (2)

Piezosurgery group

EXPERIMENTAL

In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar. Intervention: Device: Piezosurgery

Device: Piezosurgery

Conventional group

ACTIVE COMPARATOR

In the control group, conventional burs were used to remove the bone surrounding the impacted third molar. Intervention: Device: Conventional burs

Device: Conventional burs

Interventions

Piezosurgery DEVICE

Piezosurgery used as an osteotomy device

Piezosurgery group

Conventional burs DEVICE

Conventional burs used as an osteotomy device

Conventional group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II
• Aged 18-35
• Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
• Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index

You may not qualify if:

• Individuals who had systemic disease affecting bone or soft tissue metabolism
• Smokers (more than 10 cigarettes a day)
• Alcohol dependent
• Systemic disease affecting bone or soft tissue metabolism
• Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

Related Publications (12)

• Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.

  PMID: 22890087 RESULT

• Rosa AL, Carneiro MG, Lavrador MA, Novaes AB Jr. Influence of flap design on periodontal healing of second molars after extraction of impacted mandibular third molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Apr;93(4):404-7. doi: 10.1067/moe.2002.122823.

  PMID: 12029279 RESULT

• Ren YF, Malmstrom HS. Effectiveness of antibiotic prophylaxis in third molar surgery: a meta-analysis of randomized controlled clinical trials. J Oral Maxillofac Surg. 2007 Oct;65(10):1909-21. doi: 10.1016/j.joms.2007.03.004.

  PMID: 17884515 RESULT

• Piersanti L, Dilorenzo M, Monaco G, Marchetti C. Piezosurgery or conventional rotatory instruments for inferior third molar extractions? J Oral Maxillofac Surg. 2014 Sep;72(9):1647-52. doi: 10.1016/j.joms.2014.04.032. Epub 2014 May 6.

  PMID: 25109581 RESULT

• Cho H, David MC, Lynham AJ, Hsu E. Effectiveness of irrigation with chlorhexidine after removal of mandibular third molars: a randomised controlled trial. Br J Oral Maxillofac Surg. 2018 Jan;56(1):54-59. doi: 10.1016/j.bjoms.2017.11.010. Epub 2017 Dec 6.

  PMID: 29223633 RESULT

• Cicciu M, Stacchi C, Fiorillo L, Cervino G, Troiano G, Vercellotti T, Herford AS, Galindo-Moreno P, Di Lenarda R. Piezoelectric bone surgery for impacted lower third molar extraction compared with conventional rotary instruments: a systematic review, meta-analysis, and trial sequential analysis. Int J Oral Maxillofac Surg. 2021 Jan;50(1):121-131. doi: 10.1016/j.ijom.2020.03.008. Epub 2020 Apr 11.

  PMID: 32284166 RESULT

• Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.

  PMID: 25234524 RESULT

• Sortino F, Pedulla E, Masoli V. The piezoelectric and rotatory osteotomy technique in impacted third molar surgery: comparison of postoperative recovery. J Oral Maxillofac Surg. 2008 Dec;66(12):2444-8. doi: 10.1016/j.joms.2008.06.004.

  PMID: 19022121 RESULT

• Goyal M, Marya K, Jhamb A, Chawla S, Sonoo PR, Singh V, Aggarwal A. Comparative evaluation of surgical outcome after removal of impacted mandibular third molars using a Piezotome or a conventional handpiece: a prospective study. Br J Oral Maxillofac Surg. 2012 Sep;50(6):556-61. doi: 10.1016/j.bjoms.2011.10.010. Epub 2011 Nov 15.

  PMID: 22088359 RESULT

• Barone A, Marconcini S, Giacomelli L, Rispoli L, Calvo JL, Covani U. A randomized clinical evaluation of ultrasound bone surgery versus traditional rotary instruments in lower third molar extraction. J Oral Maxillofac Surg. 2010 Feb;68(2):330-6. doi: 10.1016/j.joms.2009.03.053. Epub 2010 Jan 15.

  PMID: 20116704 RESULT

• Ge J, Yang C, Zheng JW, He DM, Zheng LY, Hu YK. Four osteotomy methods with piezosurgery to remove complicated mandibular third molars: a retrospective study. J Oral Maxillofac Surg. 2014 Nov;72(11):2126-33. doi: 10.1016/j.joms.2014.05.028. Epub 2014 Jun 14.

  PMID: 25201232 RESULT

• Erdem MK, Cambazoglu M. A comparative analysis of postoperative morbidity and alveolar bone regeneration following surgical extraction of impacted lower third molar teeth using piezosurgery and conventional instruments: a split-mouth clinical investigation. Eur J Med Res. 2024 Sep 14;29(1):460. doi: 10.1186/s40001-024-02051-8.

  PMID: 39272144 DERIVED

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Murat K Erdem, PhD, DDS

  Ankara University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Murat Kaan Erdem, Ph.D, DDS. Ankara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available in 1 month and will be available for 2 years

Locations

TU (1)