- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05049382
Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Konya
-
Selçuklu, Konya, Turkey, 42250
- Selcuk University, Dentistry Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Infection after surgery
- Alveolar osteitis
- Not to participate in any follow-up control appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Difficulty
Classified as low difficulty according to Escoda's classification
|
surgical extraction of impacted mandibular third molar tooth
|
|
Experimental: Modarate Difficulty
Classified as modarate difficulty according to Escoda's classification
|
surgical extraction of impacted mandibular third molar tooth
|
|
Experimental: High Difficulty
Classified as high difficulty according to Escoda's classification
|
surgical extraction of impacted mandibular third molar tooth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operation time
Time Frame: after the operation
|
Duration of surgical intervention
|
after the operation
|
|
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.
|
before the surgery, 4th and 10th days
|
|
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.
|
before the surgery, 4th and 10th days
|
|
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.
|
before the surgery, 4th and 10th days
|
|
OHIP-14 score
Time Frame: before the surgery, 4th and 10th days
|
Oral Health Impact Profile Score(14-70; higher is worse)
|
before the surgery, 4th and 10th days
|
|
VAS score
Time Frame: 4th and 10th days
|
Visual analog scale score(0-10; higher is worse)
|
4th and 10th days
|
|
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.
|
before the surgery and 4th 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.
|
before the surgery and 4th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
interincisal distance
Time Frame: 3rd and 10th day
|
the distance between right upper central incisor incisal line and right upper incisor incisal line
|
3rd and 10th day
|
|
tragus-commissura distance
Time Frame: 3rd and 10th day
|
the distance between tragus and angulus in relevant side
|
3rd and 10th day
|
|
lateral canthus-angulus distance
Time Frame: 3rd and 10th day
|
the distance between lateral canthus and angulus in relevant side
|
3rd and 10th day
|
|
VAS score
Time Frame: 10th day
|
Visual analog scale score(0-10; higher is worse)
|
10th day
|
|
OHIP -14 score
Time Frame: 3rd, 10th and 30th day
|
Oral Health Impact Profile Score(14-70; higher is worse)
|
3rd, 10th and 30th day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gökhan Gürses, Selcuk Universty/Dentistry Faculty
- Principal Investigator: Mert Doğrul, Selcuk Universty/Dentistry Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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