Tooth Extraction Status NosNCT02200861
Tooth Extraction With Deep Sedation in Children: A Retrospective Study
An observational study of Tooth Extraction Status Nos, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Tooth Extraction Status Nos
- How many people
- 885 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2014to Sep 2014
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children
Who may be able to join
- the patients who dental treatment was performed with deep sedation
Who cannot join
- the patients who dental treatment was performed local anesthesia or general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.
Read the detailed description
Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperated patients with severe anxiety. In these patients, unpleasant dental experiences may lead to development of dental phobia when they become adults . Therefore, it is important to eradicate anxiety, and to prevent a possible psychological trauma in pediatric patients. For this purpose, psychological and medical methods have been applied to increase patient compliance. It has been proven that general anesthesia especially prevents dental phobia in elderly, and increases the quality of life related to oral health. In this study we aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.
- Conditions
- Tooth Extraction Status Nos
- Keywords
- sedation,, tooth extraction,
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthetic technics used for deep sedation
Measured: 2 month
Secondary outcomes (1)
side effects observed in patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Günay CANPOLAT, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200861
- Sponsor's protocol ID
- 2014/389
- Status last verified
- Nov 2014
- First submitted
- 24 Jul 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Extraction With Deep Sedation in Children: A Retrospective Study
- ClinicalTrials.gov ID
- NCT02200861
- Acronym / sponsor ID
- 2014/389
- Conditions
- Tooth Extraction Status Nos
- Keywords
- sedation,, tooth extraction,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.
Detailed description
Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperated patients with severe anxiety. In these patients, unpleasant dental experiences may lead to development of dental phobia when they become adults . Therefore, it is important to eradicate anxiety, and to prevent a possible psychological trauma in pediatric patients. For this purpose, psychological and medical methods have been applied to increase patient compliance. It has been proven that general anesthesia especially prevents dental phobia in elderly, and increases the quality of life related to oral health. In this study we aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children
Key inclusion criteria (1 listed)
- the patients who dental treatment was performed with deep sedation
Key exclusion criteria (1 listed)
- the patients who dental treatment was performed local anesthesia or general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
anesthetic technics used for deep sedation
Time frame: 2 month
1 secondary outcome
side effects observed in patients
Time frame: 2 months
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 5 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tooth Extraction Status Nos, run by TC Erciyes 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 1 inclusion and 1 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 5 Nov 2014. 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?
anesthetic technics used for deep sedation (time frame: 2 month). 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 5 Nov 2014.