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Completed

NCT Number: NCT04708119

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmet Altan

Tokat Province, 60030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The follicular tissues were also excised after tooth extraction.

Procedure

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 13, 2021
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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