Clinical trial NCT05545553: Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery
Official title: A Randomized Split Mouth Clinical Trial Comparing Piezosurgery and Conventional Rotary Instruments on Impacted Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Impacted Tooth
Piezo-Electric Surgery
Postoperative Complication
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change in Oral Health-related Quality of Life
timeFrame: 14 days
Secondary outcomes:
measure: Change in pain
timeFrame: 7 days
measure: Change in Mouth opening
timeFrame: 7 days
measure: Operation time
timeFrame: Intraoperative
measure: Change in facial swelling
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.