Dental Injury Related To Conventional Direct Laryngoscopy (dentalinjury)

Frequency And Level Of Dental Injury Related To Conventional Direct Laryngoscopy: A Prospective Observational Study

This research explores the occurrence of minor dental injuries and their associated effects by employing the transillumination technique with a cold light source. Unlike traditional methods primarily concentrating on major traumas detectable through standard laryngoscopy, this study aims to shed light on the subtler yet potentially impactful dental traumas that may otherwise go unnoticed. Through this innovative approach, investigators hope to gain deeper insights into the nuances of dental damage and its implications for oral health.

Study Overview

• Status: Completed
• Conditions: Intubated Patients; Laryngoscopy; Asa I-III Patients
• Intervention / Treatment: Procedure: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

Detailed Description

This study aims to investigate especially minor dental traumas and associated damages instead of major traumas that can be directly seen due to conventional laryngoscopy using transillumination technique with cold light source.

After the approval of the Selcuk University Local Institutional Ethics Committee (2017/05), 300 ASA I-III adult patients who underwent elective surgical operations under general anesthesia and underwent endotracheal intubation were included in this prospective, double-blinded study. Written informed consent was obtained from each patient during the preoperative anesthetic evaluation.

During the preoperative anesthetic evaluation, an anesthetist and dentist in the study team performed a detailed oral physical examination on all study patients. Demographic data such as age, gender, body weight, height, data related to airway management such as mallampati score, thromental distance, mouth opening size, and information about past anesthesia history, including previously described difficult intubation and medical condition, were questioned, and recorded. During a dental examination, all teeth, but particularly anterior 6 of maxillary and mandibular teeth, were examined regarding general dental hygiene and the existence of any missing teeth, tooth decay, plaque and stone formation, discoloration, gum problems such as recession and gingivitis, and tooth trauma. The patients with the presence of deformation due to a trauma or a congenital abnormality in the maxilla-fascial region, a swinging tooth, and a history of previous surgical operation regarding the maxilla-fascial region and oral cavity were not included in the study.

All patients were subjected to the same anesthetic process. None of the patients were given anesthetic premedication on the day of surgery. Anesthesia induction was achieved with 2.0 mg.kg-1 iv propofol, 2.0 mg.kg-1 iv fentanyl, and 0.6 mg.kg-1 iv rocuronium after routine monitoring with ECG, non-invasive blood pressure, and SpO2. Each patient was ventilated with a face mask with 100% O2 for 2-3 minutes and intubated with a proper endotracheal tube by the same anesthetist using a conventional laryngoscope. All intubations were achieved by anesthesiologists with different statuses (senior assistants and consultants who were blind to the study). After the endotracheal intubation, the anesthesiologist included in the study recorded the data about intubation and airway management such as Cormack-Lehane Score, laryngoscope blade type and size, difficulty in intubation, use of additional devices such as oral airway, intubating supraglottic airway device, video laryngoscope, and intubating guide in the airway management, and the number of intubating attempts by asking the practitioner.

The intraoperative dental evaluation was performed using a transillumination technique with a cold light source at two different time points: T1: Before anesthesia induction, and T2: After endotracheal intubation, before the start of the surgical operation. The same dentist performed all dental evaluations. Although all teeth were evaluated, the evaluation with the cold light source was particularly for every six teeth in the lower and upper jaws.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42130
    • Selcuk University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ASA I_III patients intubated by direct laryngoscopy under general anesthesia

Description

Inclusion Criteria:

• ASA I,II,III
• Intubated by direct laringscopy

Exclusion Criteria:

• deformation due to a trauma or a congenital abnormality in the maxilla-fascial region
• a swinging tooth
• history of previous surgical operations regarding the maxilla-fascial region

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intubated; intubated by direkt laryngoscopy under general anesthesia	Procedure: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas; endotracheal intubation by using direct laryngoscopy; Other Names: endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dental injury	frequency of dental injury due to direct laryngoscopy	1 year

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Funda Arun, Asst. Prof., Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: endotracheal intubation; general anesthesia; dental trauma; laryngoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Sevoflurane; Rocuronium; Propofol
• Other Study ID Numbers: F004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to private conditions, we do not plan to share IPD with other researchers. This decision is based on data confidentiality, participant privacy, and compliance with ethical and regulatory guidelines. While IPD sharing is not part of our plan, we are open to providing aggregate data or summary results if you'd like to.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No