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Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars

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ClinicalTrials.gov Identifier: NCT04708119
Recruitment Status : Completed
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmet Altan, Tokat Gaziosmanpasa University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Follicle Cyst Teeth, Impacted Pathology Procedure: The follicular tissues were also excised after tooth extraction. Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : July 15, 2020
Arms and Interventions
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Arm Intervention/treatment
histopathological evaluation
angulation of impacted lower mandibular third molar and histopathological evaluation
 Procedure: The follicular tissues were also excised after tooth extraction.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Data collection [ Time Frame: data collection for the first three months, ]
    The follicular tissues were also excised after tooth extraction

  2. Histopathological examination [ Time Frame: histopathological examination for 3 months ]
    The excision materials obtained for the study were subjected to routine tissue follow-up procedures


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708119


Locations
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Turkey
Ahmet Altan
Tokat, Turkey, 60030
Sponsors and Collaborators
Tokat Gaziosmanpasa University
More Information
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Responsible Party: Ahmet Altan, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT04708119    
Other Study ID Numbers: 19-KAEK-081
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases