Impacted Third Molar ToothNCT05049382
Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
A study testing Extraction of impacted mandibular third molar in people with Impacted Third Molar Tooth, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to Escoda's difficulty classification. Before the extraction, patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum… 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?
- Extraction of impacted mandibular third molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2024to 12 May 2025
- 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
- Having extraction of only the mandibular third molar
- No systemic disease
- Signing an informed consent
- No dental phobia or anxiety
- No lesion around the impacted tooth
- Presence of adjacent second molar
Who cannot join
- Infection after surgery
- Alveolar osteitis
- Not to participate in any follow-up control appointments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Dentistry Faculty
Selçuklu, Konya, 42250
About this study
The tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to Escoda's difficulty classification. Before the extraction, patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer will be measured.
Operation time will be recorded. After the operation, on 4th-day patients' patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer and Visual Analogue Scale (for pain) scores will be measured and recorded. On the 10th day, all these measurements will be repeated.
All recorded data will be evaluated for possible correlations based on extraction difficulties.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Extraction of impacted mandibular third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of impacted mandibular third molarProcedure or surgery
surgical extraction of impacted mandibular third molar tooth
| Study group | Role | What they receive |
|---|---|---|
| Low Difficulty | Experimental | Classified as low difficulty according to Escoda's classification Receives: Procedure: Extraction of impacted mandibular third molar |
| Modarate Difficulty | Experimental | Classified as modarate difficulty according to Escoda's classification Receives: Procedure: Extraction of impacted mandibular third molar |
| High Difficulty | Experimental | Classified as high difficulty according to Escoda's classification Receives: Procedure: Extraction of impacted mandibular third molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
interincisal distance change
The distance between the right upper central incisor incisal line and the right upper incisor incisal line will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
Measured: before the surgery, 4th and 10th days
tragus-commissura distance
the distance between tragus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
Measured: before the surgery, 4th and 10th days
lateral canthus-angulus distance
the distance between lateral canthus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
Measured: before the surgery, 4th and 10th days
OHIP-14 score
Oral Health Impact Profile Score(14-70; higher is worse)
Measured: before the surgery, 4th and 10th days
VAS score
Visual analog scale score(0-10; higher is worse)
Measured: 4th and 10th days
Operation time
Duration of surgical intervention
Measured: after the operation
CRP serum level
Serum levels of CRP will be measured via blood samples before the surgery and the 5th day.
Measured: before the surgery and 4th day
D-Dimer serum level
Serum levels of D-Dimer will be measured via blood samples before the surgery and the 5th day.
Measured: before the surgery and 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start9 Apr 2024
- Primary completion5 May 2025
- Study completion12 May 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Gökhan Gürses, Study chair, Selcuk Universty/Dentistry FacultyMert Doğrul, Principal investigator, Selcuk Universty/Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049382
- Sponsor's protocol ID
- SelcukU01
- Status last verified
- May 2025
- First submitted
- 10 Sep 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
- ClinicalTrials.gov ID
- NCT05049382
- Acronym / sponsor ID
- SelcukU01
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 20 Sep 2021 (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 tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to Escoda's difficulty classification. Before the extraction, patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer will be measured.
Operation time will be recorded. After the operation, on 4th-day patients' patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, Oral Health Impact Profile -14 (OHIP-14) scores, and serum levels of CRP and D-Dimer and Visual Analogue Scale (for pain) scores will be measured and recorded. On the 10th day, all these measurements will be repeated.
All recorded data will be evaluated for possible correlations based on extraction difficulties.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Difficulty | Experimental | Procedure: Extraction of impacted mandibular third molarClassified as low difficulty according to Escoda's classification |
| Modarate Difficulty | Experimental | Procedure: Extraction of impacted mandibular third molarClassified as modarate difficulty according to Escoda's classification |
| High Difficulty | Experimental | Procedure: Extraction of impacted mandibular third molarClassified as high difficulty according to Escoda's classification |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having extraction of only the mandibular third molar
- No systemic disease
- Signing an informed consent
- No dental phobia or anxiety
- No lesion around the impacted tooth
Key exclusion criteria (3 listed)
- Infection after surgery
- Alveolar osteitis
- Not to participate in any follow-up control appointments
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 |
|---|---|---|
| Extraction of impacted mandibular third molarsurgical extraction of impacted mandibular third molar tooth | Procedure or surgery | High Difficulty, Low Difficulty, Modarate Difficulty |
Primary outcome
interincisal distance change
Time frame: before the surgery, 4th and 10th days
The distance between the right upper central incisor incisal line and the right upper incisor incisal line will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
tragus-commissura distance
Time frame: before the surgery, 4th and 10th days
the distance between tragus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
lateral canthus-angulus distance
Time frame: before the surgery, 4th and 10th days
the distance between lateral canthus and angulus in relevant side will be measured before the surgery, on the 5th and 10th day. The changes will be evaluated.
OHIP-14 score
Time frame: before the surgery, 4th and 10th days
Oral Health Impact Profile Score(14-70; higher is worse)
VAS score
Time frame: 4th and 10th days
Visual analog scale score(0-10; higher is worse)
Operation time
Time frame: after the operation
Duration of surgical intervention
CRP serum level
Time frame: before the surgery and 4th day
Serum levels of CRP will be measured via blood samples before the surgery and the 5th day.
D-Dimer serum level
Time frame: before the surgery and 4th day
Serum levels of D-Dimer will be measured via blood samples before the surgery and the 5th day.
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 15 May 2025.
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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.
Gökhan Gürses study chair
Selcuk Universty/Dentistry Faculty
Mert Doğrul principal investigator
Selcuk Universty/Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction of impacted mandibular third molar in people with Impacted Third Molar Tooth, 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 6 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 15 May 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?
interincisal distance change (time frame: before the surgery, 4th and 10th days). The study lists 8 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 15 May 2025.