Dental Injury Related To Conventional Direct Laryngoscopy

NCT ID: NCT06760247

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-07-01

Brief Summary

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.

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.

Conditions

Asa I-III Patients; Intubated Patients; Laryngoscopy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

intubated

intubated by direkt laryngoscopy under general anesthesia

intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

Intervention Type: PROCEDURE

endotracheal intubation by using direct laryngoscopy

Interventions

intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

endotracheal intubation by using direct laryngoscopy

Intervention Type: PROCEDURE

Other Intervention Names

endotracheal intubation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

FUNDA ARUN

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Funda Arun, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Selcuk University Faculty of Dentistry

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

F004

Identifier Type: -

Identifier Source: org_study_id