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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • 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 Locations

    • 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

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
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

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

Investigators

  • 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)

April 9, 2024

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

May 12, 2025

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

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

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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