Micronuclei CountNCT05532514
EFFECT OF LIMITED VOLUME CONE BEAM COMPUTED TOMOGRAPHY ON MICRONUCLEI CELLS COUNT OF BUCCAL MUCOSA
An observational study of Micronuclei Count, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronuclei Count
- What is being tested?
- MICRONUCLEI COUNT
- How many people
- 63 participants
- Where
- 1 siteIndia
- Study dates
- 24 Aug 2022to 15 Dec 2022
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: - patient reporting to oral radiology for CBCT for any dental conditions
Who may be able to join
- systemically healthy individuals
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute Of Dental Science
Rohtak, Haryana, 124001
Sanjay Tewari, 01262283876, principalpgids@yahoo.in
Ambika Gupta
About this study
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)
Read the 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.
- Conditions
- Micronuclei Count
- Being tested
- MICRONUCLEI COUNT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICRONUCLEI COUNTOther
MICRONUCLEI COUNT IN PRECBCT and POSTCBCT EXPOSURE
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | exposure in 5x5 fov at 90 voxel size Receives: Other: MICRONUCLEI COUNT | |
| GROUP B | exposure in 5x5 fov at 200 voxel size Receives: Other: MICRONUCLEI COUNT |
What is being measured
The primary outcome is the main question the study is designed to answer.
THE CHANGE IN NUCLEAR DIMENSIONS WILL BE NOTICED AFTER CBCT EXPOSURE
MICROSCOPIC ANALYSIS WITH PAP SMEAR OF EXFOLIATED CELLS
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start24 Aug 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Micronuclei CountStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532514
- Sponsor's protocol ID
- Dr.Komal Kumia
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24910676Thomas 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.
PubMed 19444240da 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.
PubMed 29091472Popova 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.
PubMed 17463102Belmans 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.
PubMed 30912976Antonio 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.
PubMed 28977295
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF LIMITED VOLUME CONE BEAM COMPUTED TOMOGRAPHY ON MICRONUCLEI CELLS COUNT OF BUCCAL MUCOSA
- ClinicalTrials.gov ID
- NCT05532514
- Acronym / sponsor ID
- Dr.Komal Kumia
- Conditions
- Micronuclei Count
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 8 Sep 2022 (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.
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)
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | – | Other: MICRONUCLEI COUNTexposure in 5x5 fov at 90 voxel size |
| GROUP B | – | Other: MICRONUCLEI COUNTexposure in 5x5 fov at 200 voxel size |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - patient reporting to oral radiology for CBCT for any dental conditions
Key inclusion criteria (1 listed)
- systemically healthy individuals
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| MICRONUCLEI COUNTMICRONUCLEI COUNT IN PRECBCT and POSTCBCT EXPOSURE | Other | GROUP A, GROUP B |
Primary outcome
THE CHANGE IN NUCLEAR DIMENSIONS WILL BE NOTICED AFTER CBCT EXPOSURE
Time frame: 1 YEAR
MICROSCOPIC ANALYSIS WITH PAP SMEAR OF EXFOLIATED CELLS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Background: PubMed 24910676Arora 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.
- Background: PubMed 19444240Thomas 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.
- Background: PubMed 29091472da 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.
- Background: PubMed 17463102Popova 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.
- Background: PubMed 30912976Belmans 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.
- Background: PubMed 28977295Antonio 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.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronuclei Count, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Tewari (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THE CHANGE IN NUCLEAR DIMENSIONS WILL BE NOTICED AFTER CBCT EXPOSURE (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532514, which also lists 6 linked publications.
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 8 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.