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Asa I-III PatientsdentalinjuryNCT06760247

Dental Injury Related To Conventional Direct Laryngoscopy

An observational study of Asa I-III Patients and Intubated Patients, run by Selcuk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2017to 1 Jul 2018
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ASA I_III patients intubated by direct laryngoscopy under general anesthesia

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Selcuk University Faculty of Dentistry

    Konya, 42130

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
Keywords
dental trauma, general anesthesia, endotracheal intubation, laryngoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gasProcedure or surgery

    Also called endotracheal intubation

    endotracheal intubation by using direct laryngoscopy

Study groups in NCT06760247
Study groupRoleWhat they receive
intubatedintubated by direkt laryngoscopy under general anesthesia
Receives: Procedure: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dental injury

    frequency of dental injury due to direct laryngoscopy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Jun 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
300 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760247
Sponsor's protocol ID
F004
Acronym
dentalinjury
Status last verified
Jan 2025
First submitted
29 Dec 2024
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Asa I-III Patients and Intubated Patients, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dental injury (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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