Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedDecember 5, 2022
December 1, 2022
3.4 years
October 20, 2016
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
SOD activity in alveolar bone specimen
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
immediately after surgery
VEGF levels in alveolar bone specimen
immediately after surgery
MMP-9 level in alveolar bone specimen
immediately after surgery
Study Arms (2)
healthy, conventional surgery
ACTIVE COMPARATORSurgical bone removal by conventional rotary burs in healthy patients during third molar surgery
healthy, piezo surgery
EXPERIMENTALSurgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery
Interventions
Eligibility Criteria
You may qualify if:
- bilaterally symmetrically impacted lower third molars
You may not qualify if:
- presence of intraoral infection
- chronic orofacial pain
- pregnancy/ lactation
- heavy tobacco smokers
- alcohol/ drug abuse
- allergic reaction to medicaments used
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dental Medicine, University of Belgrade
Belgrade, 11000, Serbia
Related Publications (1)
Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
PMID: 32712962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bozidar M Brkovic, DDS,PhD
School of Dental Medicine, University of Belgrade
- PRINCIPAL INVESTIGATOR
Milan V Vucetic, PhD student
School of Dental Medicine, University of Belgrade
- PRINCIPAL INVESTIGATOR
Marija S Milic, DDS, PhD
School of Dental Medicine, University of Belgrade
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, PhD, Associate Professor
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 21, 2016
Study Start
October 1, 2016
Primary Completion
March 1, 2020
Study Completion
April 1, 2020
Last Updated
December 5, 2022
Record last verified: 2022-12