NCT04708119

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 6, 2021

Last Update Submit

January 11, 2021

Conditions

Follicle CystTeeth, ImpactedPathology

Outcome Measures

Primary Outcomes (2)

  • Data collection

    The follicular tissues were also excised after tooth extraction

    data collection for the first three months,

  • Histopathological examination

    The excision materials obtained for the study were subjected to routine tissue follow-up procedures

    histopathological examination for 3 months

Study Arms (1)

histopathological evaluation

OTHER

angulation of impacted lower mandibular third molar and histopathological evaluation

Procedure: The follicular tissues were also excised after tooth extraction.

Interventions

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.

histopathological evaluation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study

You may not qualify if:

  • individuals with systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmet Altan

Tokat Province, 60030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Follicular CystTooth, Impacted

Condition Hierarchy (Ancestors)

CystsNeoplasmsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 13, 2021

Study Start

April 1, 2019

Primary Completion

December 1, 2019

Study Completion

July 15, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

TU(1)