EFFECT OF LIMITED VOLUME CONE BEAM COMPUTED TOMOGRAPHY ON MICRONUCLEI CELLS COUNT OF BUCCAL MUCOSA

September 3, 2022 updated by: Postgraduate Institute of Dental Sciences Rohtak

title -Effect of limited Cone Beam Computed Tomography on micronucleated cell count of buccal mucosa.

Rationale: Our study aims to detect and establish a correlation between mean micronucleated cell count and nuclear morphometry in exfoliated cells from affected and apparently unaffected mucosa after CBCT radiation and compare them with exfoliated cells from normal appearing mucosa of normal subjects before CBCT. This could prove beneficial in early detection of malignant conversion of buccal mucosa after CBCT and hence improve the prognosis and better treatment outcome of the patient.

RESEARCH QUESTION-what is the effect of CBCT radiations on the no. Of micronucleated cells in the buccal mucosal cells Population- Patients Planned For CBCT Intervention- None Control-None Outcome- change in number of mean micronucleated cell count before and after the CBCT exposure Time- 1 year (Jan 2020- April 2021)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ionizing radiation is a well-known mutagen and carcinogen in the human population which has both direct and indirect effects on the tissues. It can damage the tissues through different mechanisms like breakage, cross linking of DNA strands, change or loss of the base and disruption of hydrogen bonds. These radiations cause changes in the buccal mucosa, salivary glands, dentin and enamel leading to xerostomia, mucositis and radiation related caries.

Buccal mucosal cells are under direct radiation exposure in dental radiographic techniques and act as the primary target for radiation-induced damage. Also, it has a highly proliferative epithelial cells and can be easily collected and studied. Micronuclei, an anomaly structure, originates from the chromosome fragments or whole chromosomes that lag behind at anaphase during nuclear division under physical and chemical factors. The micronucleus index has become one of the standard cytogenetic endpoints and biomarkers used in genetic toxicology in vivo or in vitro2. In healthy epithelial tissues these MNi ranges from 0.5 to 2.5 MNi /1000 cells. The studies have shown an increase in their frequency in individuals exposed to radiation or other genotoxic agents.

However, these studies observed the effect on the micronuclei at small and medium FOV, but the radiation induced damage is seen mostly at smaller FOVs which involves high resolution, thereby causing more radiation exposure.

Keeping this in mind, the aim of this study is to observe and correlate the mean micro nucleated cell count of the buccal epithelial cells with the help of PAP smear after CBCT exposure at different voxel sizes (90 and 200) at small FOV. This could prove beneficial and shed light on the cytogenetic damage and malignant conversion potential of buccal mucosa after CBCT.

Study Type

Observational

Enrollment (Anticipated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • Post Graduate Institute of Dental Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- patient reporting to oral radiology for CBCT for any dental conditions

Description

Inclusion Criteria:

  • systemically healthy individuals

Exclusion Criteria:

- Subjects with any other potentially malignant disorder present in the oral cavity. .

2. Subjects who are smokers and alcoholics. 3. Subjects with history of malignancy. 4. Subjects receiving dietary supplementations 5. Any subjects exposed to radiation or other carcinogens in the past one month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GROUP A
exposure in 5x5 fov at 90 voxel size
Other: MICRONUCLEI COUNT
MICRONUCLEI COUNT IN PRECBCT and POSTCBCT EXPOSURE
GROUP B
exposure in 5x5 fov at 200 voxel size
Other: MICRONUCLEI COUNT
MICRONUCLEI COUNT IN PRECBCT and POSTCBCT EXPOSURE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THE CHANGE IN NUCLEAR DIMENSIONS WILL BE NOTICED AFTER CBCT EXPOSURE
Time Frame: 1 YEAR
MICROSCOPIC ANALYSIS WITH PAP SMEAR OF EXFOLIATED CELLS
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

December 15, 2022

Study Registration Dates

First Submitted

September 3, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Dr.Komal Kumia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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