- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488028
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Messina (ME)
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Messina, Messina (ME), Italy, 98124
- University Hospital Policlinic Gaetano Martino
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Piezosurgery
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument
|
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. |
EXPERIMENTAL: Conventional bur
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur
|
During lower third molar surgery, osteotomy is performed using rotary instruments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial swelling
Time Frame: 7 days
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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