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

NCT05488028 | Completed

• 1 other identifier: 01-20
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Swelling/ Edema; Impacted Third Molar Tooth

Keywords

piezosurgery; conventional osteotomy; impacted lower third molar; facial scan; 3d rendering

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Piezosurgery

EXPERIMENTAL

Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument

Procedure: Piezo-electric surgery of impacted lower third molars

Conventional bur

EXPERIMENTAL

Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur

Procedure: Rotary bur surgery of impacted lower third molars

Interventions

Piezo-electric surgery of impacted lower third molars PROCEDURE

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.

Piezosurgery

Rotary bur surgery of impacted lower third molars PROCEDURE

During lower third molar surgery, osteotomy is performed using rotary instruments

Conventional bur

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• no clinical evidence of major facial asymmetry;
• use of medication that would influence or alter wound healing;
• temporomandibular joint disorder history;
• smoking

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

University Hospital Policlinic Gaetano Martino

Messina, Messina (ME), 98124, Italy

Location

Related Publications (1)

• Caputo A, Rubino E, Marciano A, Peditto M, Bellocchio AM, Nucera R, Oteri G. Three-dimensional facial swelling evaluation of piezo-electric vs conventional drilling bur surgery of impacted lower third molar: a randomized clinical trial. BMC Oral Health. 2023 Apr 21;23(1):233. doi: 10.1186/s12903-023-02910-6.

  PMID: 37085833 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth model

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: September 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)