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).
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
- Conditions the study is for
- Asa I-III Patients, Intubated Patients, Laryngoscopy
- What is being tested?
- intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Asa I-III Patients, Intubated Patients, Laryngoscopy
- 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 group | Role | What they receive |
|---|---|---|
| intubated | intubated 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.
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.
- First posted6 Jan 2025
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asa I-III PatientsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FUNDA ARUN, Selcuk University
- Investigators
- Funda Arun, Asst. Prof., Principal investigator, Selcuk University
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency And Level Of Dental Injury Related To Conventional Direct Laryngoscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06760247
- Acronym / sponsor ID
- dentalinjury / F004
- Conditions
- Asa I-III Patients, Intubated Patients, Laryngoscopy
- Keywords
- dental trauma, general anesthesia, endotracheal intubation, laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intubated | – | Procedure: intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gasintubated by direkt laryngoscopy under general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I_III patients intubated by direct laryngoscopy under general anesthesia
Key inclusion criteria (2 listed)
- ASA I,II,III
- Intubated by direct laringscopy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gasAlso: endotracheal intubationendotracheal intubation by using direct laryngoscopy | Procedure or surgery | intubated |
Primary outcome
dental injury
Time frame: 1 year
frequency of dental injury due to direct laryngoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda Arun, Asst. Prof. principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
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.