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AzTrials

Impacted Third Molar ToothNCT05545553

Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

A study testing Piezosurgery and Conventional burs in people with Impacted Third Molar Tooth, run by Marmara University at 1 site in Turkey (Türkiye).

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

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 more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Impacted Third Molar Tooth
What is being tested?
Piezosurgery and Conventional burs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2021to 1 Aug 2022
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University School of Dentistry

    Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized Split Mouth Clinical Trial Comparing Piezosurgery and Conventional Rotary Instruments on Impacted Third Molar Surgery

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.

Being tested
Piezosurgery, Conventional burs
Keywords
Impacted Tooth, Piezo-Electric Surgery, Postoperative Complication
Medical subject headings
Tooth, Impacted, Postoperative Complications

What participants receive

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

  • PiezosurgeryDevice

    Piezosurgery used as an osteotomy device

  • Conventional bursDevice

    Conventional burs used as an osteotomy device

Study groups in NCT05545553
Study groupRoleWhat they receive
Piezosurgery groupExperimentalIn the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar.
Receives: Device: Piezosurgery
Conventional groupActive comparatorIn the control group, conventional burs were used to remove the bone surrounding the impacted third molar.
Receives: Device: Conventional burs

What is being measured

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

  1. Change in Oral Health-related Quality of Life

    Evaluated by OHIP-14

    Measured: 14 days

Secondary outcomes (4)

  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 7 days

Timeline

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

  1. First posted19 Sep 2022
  2. Study start1 Oct 2021
  3. Primary completion1 Mar 2022
  4. Study completion1 Aug 2022

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545553
Sponsor's protocol ID
MUDHF_FB_0001
Status last verified
Dec 2022
First submitted
9 Sep 2022
Last updated
14 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

  • 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

  • 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

  • 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

  • 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.

    PubMed 20116704

  • 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

  • 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

  • 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

  • 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

  • Demirci A, Bayram F, Dergin G. Piezosurgery versus conventional rotary surgery for impacted third molars: A randomised, split-mouth, clinical pilot trial. Med Oral Patol Oral Cir Bucal. 2024 Jan 1;29(1):e1-e8. doi: 10.4317/medoral.25929.

    PubMed 37992138

Questions about this trial

What is this clinical trial studying?

A study testing Piezosurgery and Conventional burs in people with Impacted Third Molar Tooth, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 5 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 14 Dec 2022. 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 Turkey (Türkiye). 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?

Change in Oral Health-related Quality of Life (time frame: 14 days). 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 NCT05545553, which also lists 12 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 14 Dec 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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