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

NCT05532514 | Unknown

• 1 other identifier: Dr.Komal Kumia
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Micronuclei Count

Outcome Measures

Primary Outcomes (1)

• THE CHANGE IN NUCLEAR DIMENSIONS WILL BE NOTICED AFTER CBCT EXPOSURE

  MICROSCOPIC ANALYSIS WITH PAP SMEAR OF EXFOLIATED CELLS

  1 YEAR

Study Arms (2)

GROUP A

exposure in 5x5 fov at 90 voxel size

Other: MICRONUCLEI COUNT

GROUP B

exposure in 5x5 fov at 200 voxel size

Other: MICRONUCLEI COUNT

Interventions

MICRONUCLEI COUNT OTHER

MICRONUCLEI COUNT IN PRECBCT and POSTCBCT EXPOSURE

GROUP A; GROUP B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• systemically healthy individuals

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute Of Dental Science

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (6)

• Arora P, Devi P, Wazir SS. Evaluation of genotoxicity in patients subjected to panoramic radiography by micronucleus assay on epithelial cells of the oral mucosa. J Dent (Tehran). 2014 Jan;11(1):47-55. Epub 2014 Jan 31.

  PMID: 24910676 BACKGROUND

• Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.

  PMID: 19444240 BACKGROUND

• da Fonte JB, Andrade TM, Albuquerque RL Jr, de Melo MFB, Takeshita WM. Evidence of genotoxicity and cytotoxicity of X-rays in the oral mucosa epithelium of adults subjected to cone beam CT. Dentomaxillofac Radiol. 2018 Feb;47(2):20170160. doi: 10.1259/dmfr.20170160. Epub 2017 Nov 13.

  PMID: 29091472 BACKGROUND

• Popova L, Kishkilova D, Hadjidekova VB, Hristova RP, Atanasova P, Hadjidekova VV, Ziya D, Hadjidekov VG. Micronucleus test in buccal epithelium cells from patients subjected to panoramic radiography. Dentomaxillofac Radiol. 2007 Mar;36(3):168-71. doi: 10.1259/dmfr/29193561.

  PMID: 17463102 BACKGROUND

• Belmans N, Gilles L, Virag P, Hedesiu M, Salmon B, Baatout S, Lucas S, Jacobs R, Lambrichts I, Moreels M. Method validation to assess in vivo cellular and subcellular changes in buccal mucosa cells and saliva following CBCT examinations. Dentomaxillofac Radiol. 2019 Sep;48(6):20180428. doi: 10.1259/dmfr.20180428. Epub 2019 Apr 5.

  PMID: 30912976 BACKGROUND

• Antonio EL, Nascimento AJD, Lima AAS, Leonart MSS, Fernandes A. GENOTOXICITY AND CYTOTOXICITY OF X-RAYS IN CHILDREN EXPOSED TO PANORAMIC RADIOGRAPHY. Rev Paul Pediatr. 2017 Jul-Sep;35(3):296-301. doi: 10.1590/1984-0462/;2017;35;3;00010. Epub 2017 Jul 20.

  PMID: 28977295 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buccal epithelial cells will be collected from each subject by principal investigator which will be subjected to exfoliative cytology. Prior to cell collection, the patients will be asked to rinse their mouth with water to remove saliva, food particles or any other debris. Cells will be obtained by gentle scraping with a metal spatula and transferred to a tube containing normal saline which will be followed by centrifugation at the rate of 1000rpm for 3 min, thrice. The suspension will be fixed with a fixative (methanol: acetic acid in the ratio 3:1) dropped onto the clean slides after that slides to be stained by the Papanicolaou stain.

Central Study Contacts

Sanjay Tewari

CONTACT

01262283876; principalpgidsrohtak@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 8, 2022
• Study Start: August 24, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

IN (1)