Impacted Third Molar ToothNCT03747237
Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
A study testing Edema measurement methods in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Edema measurement methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 31 Dec 2018
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion)
- Patients with any chronic disease and allergy
Who cannot join
- Smoking
- Pregnancy or lactation
- pericoronitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Dentistry
Konya, Karatay, 42050
About this study
The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.
Read the detailed description
The patients will be selected among the patients who apply for mandibular impacted third molar extraction to Necmettin Erbakan University, Faculty of Dentistry. A total of 60 patients will be included. All third molar operations will be carried out by the same surgeon in all groups with the same technique.Two methods will be used to evaluate the edema on the face.
- Method The surgeon will measure from three different places on the patient's face ( two point distance) with the help of a paper ruler.
- Tragus-Pogonion
- Tragus-Labial Komissura
- Angulus Mandibula-Lateral Kantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.
- Method Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 4 will be pointed on the scale postoperative 2. and 7. days.
A correlation between the results of the first and second methods will be examined.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Edema measurement methods
- Keywords
- edema, third molar
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edema measurement methodsOther
A correlation between the results of the first and second methods will be examined.
| Study group | Role | What they receive |
|---|---|---|
| 1. method, Edema measurement methods | Experimental | The surgeon will measure from three different places on the patient's face with the help of a paper ruler to measure the edema.
Tragus-Pogonion Tragus-Labial Comissura Angulus Mandible-Latheral Cantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre. Receives: Other: Edema measurement methods |
| 2. method, Edema measurement methods | No intervention | Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 5 will be pointed on the scale postoperative 2. and 7. days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tragus-pogonion measurement will be made with paper ruler.
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Measured: Up to 1week
Tragus-labial comissura measurement will be made with paper ruler.
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Measured: Up to 1week
Angulus mandible-latheral cantus will be made with paper ruler
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Measured: Up to 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start15 Nov 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Menziletoglu, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Dilek Menziletoglu, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747237
- Sponsor's protocol ID
- NEU
- Status last verified
- Nov 2018
- First submitted
- 21 Sep 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
- ClinicalTrials.gov ID
- NCT03747237
- Acronym / sponsor ID
- NEU
- Conditions
- Impacted Third Molar Tooth
- Keywords
- edema, third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Nov 2018 (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.
The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.
Detailed description
The patients will be selected among the patients who apply for mandibular impacted third molar extraction to Necmettin Erbakan University, Faculty of Dentistry. A total of 60 patients will be included. All third molar operations will be carried out by the same surgeon in all groups with the same technique.Two methods will be used to evaluate the edema on the face.
- Method The surgeon will measure from three different places on the patient's face ( two point distance) with the help of a paper ruler.
- Tragus-Pogonion
- Tragus-Labial Komissura
- Angulus Mandibula-Lateral Kantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.
- Method Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 4 will be pointed on the scale postoperative 2. and 7. days.
A correlation between the results of the first and second methods will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. method, Edema measurement methods | Experimental | Other: Edema measurement methodsThe surgeon will measure from three different places on the patient's face with the help of a paper ruler to measure the edema. Tragus-Pogonion Tragus-Labial Comissura Angulus Mandible-Latheral Cantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre. |
| 2. method, Edema measurement methods | No intervention | –Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 5 will be pointed on the scale postoperative 2. and 7. days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion)
- Patients with any chronic disease and allergy
Key exclusion criteria (3 listed)
- Smoking
- Pregnancy or lactation
- pericoronitis
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 |
|---|---|---|
| Edema measurement methodsA correlation between the results of the first and second methods will be examined. | Other | 1. method, Edema measurement methods |
Primary outcome
Tragus-pogonion measurement will be made with paper ruler.
Time frame: Up to 1week
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Tragus-labial comissura measurement will be made with paper ruler.
Time frame: Up to 1week
The measurement will be done on the 2. and 7. postoperative day and preoperative.
Angulus mandible-latheral cantus will be made with paper ruler
Time frame: Up to 1week
The measurement will be done on the 2. and 7. postoperative day and preoperative.
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 4 Jan 2019.
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Periodontal Defect
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Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
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Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
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Not yet recruiting
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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.
Dilek Menziletoglu principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edema measurement methods in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi 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 4 Jan 2019. 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?
Tragus-pogonion measurement will be made with paper ruler. (time frame: Up to 1week). The study lists 3 primary outcomes in all. 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 4 Jan 2019.