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

Primary Purpose

Impacted Third Molar Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extraction of impacted mandibular third molar
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Having extraction of only mandibular third molar No systemic disease Signing informed consent Participate all follow up control appointments

Exclusion Criteria:

Infection at surgery zone Alveolar osteitis

Sites / Locations

  • Selcuk University, Dentistry FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Pell-Gregory Classification Group 1-A

Pell-Gregory Classification Group 1-B

Pell-Gregory Classification Group 1-C

Pell-Gregory Classification Group 2-A

Pell-Gregory Classification Group 2-B

Pell-Gregory Classification Group 2-C

Pell-Gregory Classification Group 3-B

Pell-Gregory Classification Group 3-C

Arm Description

Classified as Group 1-A according to Pell-Gregory Classification

Classified as Group 1-B according to Pell-Gregory Classification

Classified as Group 1-C according to Pell-Gregory Classification

Classified as Group 2-A according to Pell-Gregory Classification

Classified as Group 2-B according to Pell-Gregory Classification

Classified as Group 2-C according to Pell-Gregory Classification

Classified as Group 3-B according to Pell-Gregory Classification

Classified as Group 3-C according to Pell-Gregory Classification

Outcomes

Primary Outcome Measures

interincisal distance
the distance between right upper central incisor incisal line and right upper incisor incisal line
tragus-commissura distance
the distance between tragus and angulus in relevant side
lateral canthus-angulus distance
the distance between lateral canthus and angulus in relevant side
OHIP-14 score
Oral Health Impact Profile Score(14-70; higher is worse)
VAS score
Visual analog scale score(0-10; higher is worse)
Operation time
Duration of surgical intervention

Secondary Outcome Measures

interincisal distance
the distance between right upper central incisor incisal line and right upper incisor incisal line
tragus-commissura distance
the distance between tragus and angulus in relevant side
lateral canthus-angulus distance
the distance between lateral canthus and angulus in relevant side
VAS score
Visual analog scale score(0-10; higher is worse)
OHIP -14 score
Oral Health Impact Profile Score(14-70; higher is worse)

Full Information

First Posted
September 10, 2021
Last Updated
August 29, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05049382
Brief Title
Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
Official Title
Does Extraction Difficulty of Mandibular Impacted Third Molars Mirror Post-op Outcomes?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The tooth of the patient who applies to the clinic for the impacted wisdom tooth will be classified according to Pell-Gregory and Winter Classifications. Before the extraction, patients' interincisal, tragus-commissural, and lateral canthus-angulus distances, and Oral Health Impact Profile -14 (OHIP-14) scores will be measured. Operation time will be recorded. After the operation, on 3rd-day patients' interincisal, tragus-commissural and lateral canthus-angulus distances, OHIP-14 scores, and Visual Analogue Scale scores will be recorded. On the 7th and 14th day, all these measurements will be replied. On the 30th day and the 60th day, OHIP-14 scores will be measured again. All these data will be evaluated to find any correlation between; operation time, classification, and post-op outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
All measurements will be made by a researcher who does not know whether it is a preop or postop measurement, which tooth will be extracted, and the classification of the tooth.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pell-Gregory Classification Group 1-A
Arm Type
Experimental
Arm Description
Classified as Group 1-A according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 1-B
Arm Type
Experimental
Arm Description
Classified as Group 1-B according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 1-C
Arm Type
Experimental
Arm Description
Classified as Group 1-C according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 2-A
Arm Type
Experimental
Arm Description
Classified as Group 2-A according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 2-B
Arm Type
Experimental
Arm Description
Classified as Group 2-B according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 2-C
Arm Type
Experimental
Arm Description
Classified as Group 2-C according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 3-B
Arm Type
Experimental
Arm Description
Classified as Group 3-B according to Pell-Gregory Classification
Arm Title
Pell-Gregory Classification Group 3-C
Arm Type
Experimental
Arm Description
Classified as Group 3-C according to Pell-Gregory Classification
Intervention Type
Procedure
Intervention Name(s)
Extraction of impacted mandibular third molar
Intervention Description
surgical extraction of impacted mandibular third molar tooth
Primary Outcome Measure Information:
Title
interincisal distance
Description
the distance between right upper central incisor incisal line and right upper incisor incisal line
Time Frame
0th day
Title
tragus-commissura distance
Description
the distance between tragus and angulus in relevant side
Time Frame
0th day
Title
lateral canthus-angulus distance
Description
the distance between lateral canthus and angulus in relevant side
Time Frame
0th day
Title
OHIP-14 score
Description
Oral Health Impact Profile Score(14-70; higher is worse)
Time Frame
0th day
Title
VAS score
Description
Visual analog scale score(0-10; higher is worse)
Time Frame
3rd day
Title
Operation time
Description
Duration of surgical intervention
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
interincisal distance
Description
the distance between right upper central incisor incisal line and right upper incisor incisal line
Time Frame
3rd and 10th day
Title
tragus-commissura distance
Description
the distance between tragus and angulus in relevant side
Time Frame
3rd and 10th day
Title
lateral canthus-angulus distance
Description
the distance between lateral canthus and angulus in relevant side
Time Frame
3rd and 10th day
Title
VAS score
Description
Visual analog scale score(0-10; higher is worse)
Time Frame
10th day
Title
OHIP -14 score
Description
Oral Health Impact Profile Score(14-70; higher is worse)
Time Frame
3rd, 10th and 30th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 At least 35 mm mouth opening Non-rooted or parallel-rooted tooth Partial bony impaction or intraosseous impacted tooth Presence of infection at the surgery zone Exclusion Criteria: Infection after surgery Alveolar osteitis Not to participate in any follow-up control appointments Lasting less than 10 minutes or more than 50 minutes operations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gökhan Gürses
Phone
5052595359
Email
gokhan0gurses@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökhan Gürses
Organizational Affiliation
Selcuk Universty/Dentistry Faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Selcuk University, Dentistry Faculty
City
Selçuklu
State/Province
Konya
ZIP/Postal Code
42250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gökhan Gürses
Phone
+905052595359
Email
gokhan0gurses@gmail.com
First Name & Middle Initial & Last Name & Degree
Adil Ersoy

12. IPD Sharing Statement

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

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