3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT

Impacted Third Molar Tooth Clinical Trial

Official title:

Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488028
• Other study ID #: 01-20
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2022
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• good general health conditions;

• presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

Exclusion Criteria:

• no clinical evidence of major facial asymmetry;

• use of medication that would influence or alter wound healing;

• temporomandibular joint disorder history;

• smoking

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• Piezo-electric surgery of impacted lower third molars
During lower third molar surgery, osteotomy is performed using piezoelectric instrumentation. When necessary, tooth sectioning was performed with a high-speed tungsten carbide slit drill under saline irrigation and the tooth removed in single or multiple segments.
• Rotary bur surgery of impacted lower third molars
During lower third molar surgery, osteotomy is performed using rotary instruments

Locations

Country	Name	City	State
Italy	University Hospital Policlinic Gaetano Martino	Messina	Messina (ME)

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial swelling	T0-T1 and T0-T2 scans are opened and superimposed through three reference points: endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella).; After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.	7 days