Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
Primary Purpose
Follicle Cyst, Teeth, Impacted, Pathology
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The follicular tissues were also excised after tooth extraction.
Sponsored by
About this trial
This is an interventional diagnostic trial for Follicle Cyst
Eligibility Criteria
Inclusion Criteria:
The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study
Exclusion Criteria:
individuals with systemic disease
Sites / Locations
- Ahmet Altan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
histopathological evaluation
Arm Description
angulation of impacted lower mandibular third molar and histopathological evaluation
Outcomes
Primary Outcome Measures
Data collection
The follicular tissues were also excised after tooth extraction
Histopathological examination
The excision materials obtained for the study were subjected to routine tissue follow-up procedures
Secondary Outcome Measures
Full Information
NCT ID
NCT04708119
First Posted
January 6, 2021
Last Updated
January 11, 2021
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT04708119
Brief Title
Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
Official Title
Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa 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
This study aimed to evaluate the incidence of histopathologic changes in dental follicles associated with radiographically normal impacted lower third molar and to determine the relationship between cystic changes in follicle tissues and age, gender, and the angular position of the impacted tooth.
Detailed Description
Patients One hundred one healthy patients whose ILTM were extracted for various reasons in Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery were included in the study. All participants included in the study signed an informed consent form. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by Tokat Gaziosmanpaşa University Clinical Research Ethics Committee for the study (Project number: 19-KAEK-081).
The patients' panoramic radiographs were examined, and the impacted teeth were divided into four groups as vertical, horizontal, mesioangular, and distoangular according to their angular positions. The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study. The follicular tissues were also excised after tooth extraction. Soft tissue samples taken during surgical removal of ILTM were evaluated in the department of pathology.
Histopathological evaluation The excision materials obtained for the study were subjected to routine tissue follow-up procedures in Tokat Gaziosmanpaşa University, Faculty of Medicine, Pathology Department. The samples were fixed in 10% formalin solution for 24 hours for light microscope examination and blocked using the routine paraffin blocking method. The preparations were prepared by obtaining sections with microtome from the blocks. These preparations were stained with Hematoxylin Eosin and evaluated under a light microscope. In the histopathological examination, squamous epithelium, keratinization, odontogenic epithelial residue, and fibrosis were evaluated as either present or absent, and inflammation was scored as 0-absent, 1-mild, 2-moderate, or 3-severe. During the microscopic evaluation of follicular tissues, soft tissue samples with stratified squamous epithelium were identified as cystic.
The relationship between histopathological changes observed in the radiographically normal dental follicles and gender and the teeth' angular positions was statistically evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicle Cyst, Teeth, Impacted, Pathology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
histopathological evaluation
Arm Type
Other
Arm Description
angulation of impacted lower mandibular third molar and histopathological evaluation
Intervention Type
Procedure
Intervention Name(s)
The follicular tissues were also excised after tooth extraction.
Intervention Description
The follicular tissues were also excised after tooth extraction. Soft tissue samples taken during surgical removal of ILTM were evaluated in the department of pathology.
Primary Outcome Measure Information:
Title
Data collection
Description
The follicular tissues were also excised after tooth extraction
Time Frame
data collection for the first three months,
Title
Histopathological examination
Description
The excision materials obtained for the study were subjected to routine tissue follow-up procedures
Time Frame
histopathological examination for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study
Exclusion Criteria:
individuals with systemic disease
Facility Information:
Facility Name
Ahmet Altan
City
Tokat
ZIP/Postal Code
60030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
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