Follicle CystNCT04708119
Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
A study testing The follicular tissues were also excised after tooth extraction. in people with Follicle Cyst and Teeth, Impacted, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Follicle Cyst, Teeth, Impacted, Pathology
- What is being tested?
- The follicular tissues were also excised after tooth extraction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study
Who cannot join
- individuals with systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Follicle Cyst, Teeth, Impacted, Pathology
- Being tested
- The follicular tissues were also excised after tooth extraction.
- Medical subject headings
- Follicular Cyst, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The follicular tissues were also excised after tooth extraction.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| histopathological evaluation | Other | angulation of impacted lower mandibular third molar and histopathological evaluation Receives: Procedure: The follicular tissues were also excised after tooth extraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection
The follicular tissues were also excised after tooth extraction
Measured: data collection for the first three months,
Histopathological examination
The excision materials obtained for the study were subjected to routine tissue follow-up procedures
Measured: histopathological examination for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicle CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Altan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708119
- Sponsor's protocol ID
- 19-KAEK-081
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathologic Changes in Dental Follicle Associated With Radiographically Normal Impacted Lower Third Molars
- ClinicalTrials.gov ID
- NCT04708119
- Acronym / sponsor ID
- 19-KAEK-081
- Conditions
- Follicle Cyst, Teeth, Impacted, Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| histopathological evaluation | Other | Procedure: The follicular tissues were also excised after tooth extraction.angulation of impacted lower mandibular third molar and histopathological evaluation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The radiographically found that patients with a follicular width of less than 2.5 mm were included in the study
Key exclusion criteria (1 listed)
- individuals with systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | histopathological evaluation |
Primary outcome
Data collection
Time frame: data collection for the first three months,
The follicular tissues were also excised after tooth extraction
Histopathological examination
Time frame: histopathological examination for 3 months
The excision materials obtained for the study were subjected to routine tissue follow-up procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The follicular tissues were also excised after tooth extraction. in people with Follicle Cyst and Teeth, Impacted, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection (time frame: data collection for the first three months,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.