NCT03747237

Brief Summary

The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 4, 2019

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

September 21, 2018

Last Update Submit

January 3, 2019

Conditions

Keywords

edemathird molar

Outcome Measures

Primary Outcomes (3)

  • Tragus-pogonion measurement will be made with paper ruler.

    The measurement will be done on the 2. and 7. postoperative day and preoperative.

    Up to 1week

  • Tragus-labial comissura measurement will be made with paper ruler.

    The measurement will be done on the 2. and 7. postoperative day and preoperative.

    Up to 1week

  • Angulus mandible-latheral cantus will be made with paper ruler

    The measurement will be done on the 2. and 7. postoperative day and preoperative.

    Up to 1week

Study Arms (2)

1. method, Edema measurement methods

EXPERIMENTAL

The surgeon will measure from three different places on the patient's face with the help of a paper ruler to measure the edema. Tragus-Pogonion Tragus-Labial Comissura Angulus Mandible-Latheral Cantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.

Other: Edema measurement methods

2. method, Edema measurement methods

NO INTERVENTION

Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 5 will be pointed on the scale postoperative 2. and 7. days.

Interventions

A correlation between the results of the first and second methods will be examined.

1. method, Edema measurement methods

Eligibility Criteria

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

You may qualify if:

  • Impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion)
  • Patients with any chronic disease and allergy

You may not qualify if:

  • Smoking
  • Pregnancy or lactation
  • pericoronitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Karatay, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dilek Menziletoglu

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 21, 2018

First Posted

November 20, 2018

Study Start

November 15, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 4, 2019

Record last verified: 2018-11

Locations