Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05545553
Other study ID # MUDHF_FB_0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date August 1, 2022

Study information

Verified date December 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Piezosurgery
Piezosurgery used as an osteotomy device
Conventional burs
Conventional burs used as an osteotomy device

Locations

Country Name City State
Turkey Marmara University School of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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 Apr 28;: — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Oral Health-related Quality of Life Evaluated by OHIP-14 14 days
Secondary 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 7 days
Secondary 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. 7 days
Secondary 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. Intraoperative
Secondary 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.
7 days
See also
  Status Clinical Trial Phase
Completed NCT06023524 - The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients N/A
Completed NCT02547896 - Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction. Phase 4
Completed NCT05684601 - Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery N/A
Completed NCT05170516 - The Effect of Saline Irrigation at Different Temperatures on Pain, Edema, and Trismus After Impacted Third Molar Surgery N/A
Completed NCT02481700 - Epidemiological Study on the Surgical Removal of Third Molars
Completed NCT05488028 - 3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT N/A
Completed NCT05679973 - Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery N/A
Recruiting NCT03741894 - Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery Phase 4
Completed NCT06017570 - Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars N/A
Completed NCT03894722 - Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery Phase 4
Completed NCT02831374 - Effectiveness of Platelet Rich Plasma in Wound Healing Phase 0
Completed NCT02837614 - Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery Phase 0
Completed NCT02494856 - Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal Phase 4
Completed NCT02450487 - Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery Phase 4
Recruiting NCT03619460 - Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction N/A
Not yet recruiting NCT05143359 - Accuracy of Variables for Impacted Mandibular Third Molar Surgery N/A
Completed NCT03784638 - Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery N/A
Completed NCT03752255 - Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery N/A
Active, not recruiting NCT04349579 - Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine Phase 4
Completed NCT03747237 - Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery. N/A