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CompletedNCT06262841Updated Feb 16, 2024

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

An interventional study of Piezosurgery and Conventional burs in Impacted Third Molar Tooth, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Ankara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2022, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the detailed description

The aim of our study is to comparatively evaluate the duration of the operation and the pain, trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical extractions of impacted lower third molar teeth using piezosurgery and traditional rotary instruments.

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Conditions studied

  • Impacted Third Molar Tooth

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03

In context

Tooth, Impacted

195 studies on the registry are indexed under Tooth, Impacted; 20 are open to participants now.

This study's enrollment of 21 is below the median of 53 across 164 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Piezosurgery group

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

    Device: Piezosurgery

  • Active comparator
    Conventional group

    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

  • DevicePiezosurgery

    Piezosurgery used as an osteotomy device

  • DeviceConventional burs

    Conventional burs used as an osteotomy device

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What researchers measure

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: Time Frame: 14 days

Secondary outcomes

  1. Change in pain

    Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable

    Time frame: 7 days

  2. Change in Mouth opening

    The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.

    Time frame: 7 days

  3. Operation time

    The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.

    Time frame: Intraoperative

  4. Change in facial swelling

    With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.

    Time frame: 7 days

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Study locations

1 site
  • Ankara University Faculty of Dentistry
    Ankara, Çankaya 06510, Turkey
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References and documents

Publications

  • 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. PubMed 22890087 ↗
  • 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. PubMed 12029279 ↗
  • 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. PubMed 17884515 ↗
  • 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. PubMed 25109581 ↗
  • 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. PubMed 29223633 ↗
  • 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. PubMed 32284166 ↗
  • 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. PubMed 25234524 ↗
  • 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. PubMed 19022121 ↗
  • 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. PubMed 22088359 ↗
  • 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. Erratum In: J Oral Maxillofac Surg. 2018 Jul;76(7):1594. doi: 10.1016/j.joms.2018.04.003. PubMed 20116704 ↗
  • 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. PubMed 25201232 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06262841
Lead sponsor
Ankara University
Responsible party
Murat Kaan Erdem (Murat Kaan Erdem, Ph.D, DDS. Ankara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara University) — Principal investigator
First posted
Feb 16, 2024
Start date
Nov 1, 2022
Primary completion
Apr 1, 2023
Completion
Apr 1, 2023
Last update
Feb 16, 2024

Study contacts

Murat K Erdem, PhD, DDS
study director · Ankara University Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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