Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?

May 12, 2025 updated by: Gokhan Gurses, Selcuk University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Konya
      • Selçuklu, Konya, Turkey, 42250
        • Selcuk University, Dentistry Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Difficulty
Classified as low difficulty according to Escoda's classification
Procedure: Extraction of impacted mandibular third molar
surgical extraction of impacted mandibular third molar tooth
Experimental: Modarate Difficulty
Classified as modarate difficulty according to Escoda's classification
Procedure: Extraction of impacted mandibular third molar
surgical extraction of impacted mandibular third molar tooth
Experimental: High Difficulty
Classified as high difficulty according to Escoda's classification
Procedure: Extraction of impacted mandibular third molar
surgical extraction of impacted mandibular third molar tooth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gökhan Gürses, Selcuk Universty/Dentistry Faculty
  • Principal Investigator: Mert Doğrul, Selcuk Universty/Dentistry Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SelcukU01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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