NCT05049382

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

September 10, 2021

Last Update Submit

May 12, 2025

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    before the surgery, 4th and 10th days

  • OHIP-14 score

    Oral Health Impact Profile Score(14-70; higher is worse)

    before the surgery, 4th and 10th days

  • VAS score

    Visual analog scale score(0-10; higher is worse)

    4th and 10th days

  • Operation time

    Duration of surgical intervention

    after the operation

  • CRP serum level

    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

    Serum levels of D-Dimer will be measured via blood samples before the surgery and the 5th day.

    before the surgery and 4th day

Study Arms (3)

Low Difficulty

EXPERIMENTAL

Classified as low difficulty according to Escoda's classification

Procedure: Extraction of impacted mandibular third molar

Modarate Difficulty

EXPERIMENTAL

Classified as modarate difficulty according to Escoda's classification

Procedure: Extraction of impacted mandibular third molar

High Difficulty

EXPERIMENTAL

Classified as high difficulty according to Escoda's classification

Procedure: Extraction of impacted mandibular third molar

Interventions

Extraction of impacted mandibular third molarPROCEDURE

surgical extraction of impacted mandibular third molar tooth

High DifficultyLow DifficultyModarate Difficulty

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Infection after surgery
  • Alveolar osteitis
  • Not to participate in any follow-up control appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Dentistry Faculty

Selçuklu, Konya, 42250, Turkey (Türkiye)

Location

Study Officials

  • Gökhan Gürses

    Selcuk Universty/Dentistry Faculty

    STUDY CHAIR

  • Mert Doğrul

    Selcuk Universty/Dentistry Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 20, 2021

Study Start

April 9, 2024

Primary Completion

May 5, 2025

Study Completion

May 12, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

TU(1)