Precancerous ConditionsNCT05215860
Photographic Evidence of Oral Precancerous Lesions in Current Tobacco and Areca Nut Users Improves Their Quit Rates
A study testing Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders and visual exposure to personal intraoral photographs of oral lesions at baseline and review in people with Precancerous Conditions, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Precancerous Conditions
- What is being tested?
- Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders and visual exposure to personal intraoral photographs of oral lesions at baseline and review
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2020to 30 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current tobacco and areca nut users.
- Presence of oral potentially malignant disorders
Who cannot join
- Any oral lesion suspicious of malignancy.
Trial locations and contacts
1 site in 1 country.
India1 site
Oral Medicine and Radiology, CDER, AIIMS
New Delhi, National Capital Territory of Delhi, 100029
About this study
Official title: Visual Communication Through Personal Intraoral Photographs of Oral Potentially Malignant Disorders in Current Tobacco and Areca Nut Users Improves Habit Abstinence: a Pilot Interventional Study
The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. A prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and OPMD were randomly divided in two groups. Group A ( n=100; Habit cessation counselling with general and medical management for OPMD). Group B ( n=100; Habit cessation counselling with general and medical management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review).
Read the detailed description
A prospective pilot interventional study was carried out in a Oral Medicine unit at a tertiary referral center where OPMD and Oral cancer screening is carried out routinely in all patients examined in the Out Patient Department (OPD). Ethical clearance for conducting the study and taking serial intraoral photographs of OPMD in consenting participants was obtained from the Institute Ethics Committee.All patients in OPD were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the Tobacco Cessation Clinic (TCC) for individual counselling session.This counselling was based on the toolkit issued by the World Health Organization (WHO) for delivering brief tobacco intervention under WHO capacity building training package.The patients then underwent detailed intraoral examination for any oral mucosal changes. Those patients that were diagnosed as having any OPMD as per clinical diagnostic criteria were then recruited as participants in the study. A total of 200 participants with current tobacco and areca nut habits and OPMDs were recruited after informed written consent and randomly assigned to the two groups. The Control Group A had 100 participants who received standard management protocol for OPMD. The experimental Group B received all the management as in Control Group A but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. All the participants were reviewed at 1, 3 and 6 months for surveillance of OPMD lesions and habit status.The data was analysed for statistically significant differences between the two groups p<0.05.
- Conditions
- Precancerous Conditions
- Being tested
- Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders, visual exposure to personal intraoral photographs of oral lesions at baseline and review
- Keywords
- cessation, tobacco use, smokeless tobacco, areca, intraoral photography, abstinence
- Medical subject headings
- Precancerous Conditions, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant DisordersBehavioural
WHO toolkit for Tobacco cessation (5A's and 5R's model)
visual exposure to personal intraoral photographs of oral lesions at baseline and reviewOther
Chairside digital intraoral photographs of oral potentially malignant disorder with smart phone and showing the photograph to the participant explaining the abnormal areas of concern
| Study group | Role | What they receive |
|---|---|---|
| Habit cessation counselling with management for OPMD | Active comparator | n=100; Habit cessation counselling with general and medical management for OPMD Receives: Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders |
| Habit cessation counselling, management for OPMD and intraoral photographs | Experimental | n=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review Receives: Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders; Other: visual exposure to personal intraoral photographs of oral lesions at baseline and review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habit quit rates
Discontinuation of habit more than 1 month.
Measured: 6 months
Secondary outcomes (4)
Size of oral lesions
Change in size of lesions from baseline in millimeters
Measured: 6 months
Oral burning sensation
Change in oral burning sensation from baseline Visual Analogue Scale (VAS) scale 0-10; 0: No oral burning sensation; 10: Worst oral burning sensation
Measured: 6 months
Colour of oral lesions
Change in colour of oral lesions from red to white
Measured: 6 months
Inter incisal mouth opening
Change in interincisal mouth opening from baseline in millimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Sep 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective pilot interventional longitudinal study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shalini Gupta, All India Institute of Medical Sciences
- Investigators
- Shalini Gupta, MDS,FDSRCS, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215860
- Sponsor's protocol ID
- IEC-616
- Status last verified
- Jan 2022
- First submitted
- 25 Dec 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data can be made available on request via email to principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Communication Through Personal Intraoral Photographs of Oral Potentially Malignant Disorders in Current Tobacco and Areca Nut Users Improves Habit Abstinence: a Pilot Interventional Study
- ClinicalTrials.gov ID
- NCT05215860
- Acronym / sponsor ID
- IEC-616
- Conditions
- Precancerous Conditions
- Keywords
- cessation, tobacco use, smokeless tobacco, areca, intraoral photography, abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Jan 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.
The success of tobacco and areca nut cessation programs in individuals with Oral Potentially Malignant Disorders (OPMDs) is imperative for risk reduction and prevention of oral cancer. A prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and OPMD were randomly divided in two groups. Group A ( n=100; Habit cessation counselling with general and medical management for OPMD). Group B ( n=100; Habit cessation counselling with general and medical management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review).
Detailed description
A prospective pilot interventional study was carried out in a Oral Medicine unit at a tertiary referral center where OPMD and Oral cancer screening is carried out routinely in all patients examined in the Out Patient Department (OPD). Ethical clearance for conducting the study and taking serial intraoral photographs of OPMD in consenting participants was obtained from the Institute Ethics Committee.All patients in OPD were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the Tobacco Cessation Clinic (TCC) for individual counselling session.This counselling was based on the toolkit issued by the World Health Organization (WHO) for delivering brief tobacco intervention under WHO capacity building training package.The patients then underwent detailed intraoral examination for any oral mucosal changes. Those patients that were diagnosed as having any OPMD as per clinical diagnostic criteria were then recruited as participants in the study. A total of 200 participants with current tobacco and areca nut habits and OPMDs were recruited after informed written consent and randomly assigned to the two groups. The Control Group A had 100 participants who received standard management protocol for OPMD. The experimental Group B received all the management as in Control Group A but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. All the participants were reviewed at 1, 3 and 6 months for surveillance of OPMD lesions and habit status.The data was analysed for statistically significant differences between the two groups p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A prospective pilot interventional longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Habit cessation counselling with management for OPMD | Active comparator | Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disordersn=100; Habit cessation counselling with general and medical management for OPMD |
| Habit cessation counselling, management for OPMD and intraoral photographs | Experimental | Behavioral: Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders, Other: visual exposure to personal intraoral photographs of oral lesions at baseline and reviewn=100; Habit cessation counselling with standard management for OPMD and visual exposure to personal intraoral photographs of oral lesions at baseline and review |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current tobacco and areca nut users.
- Presence of oral potentially malignant disorders
Key exclusion criteria (1 listed)
- Any oral lesion suspicious of malignancy.
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 |
|---|---|---|
| Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant DisordersWHO toolkit for Tobacco cessation (5A's and 5R's model) | Behavioural | Habit cessation counselling with management for OPMD, Habit cessation counselling, management for OPMD and intraoral photographs |
| visual exposure to personal intraoral photographs of oral lesions at baseline and reviewChairside digital intraoral photographs of oral potentially malignant disorder with smart phone and showing the photograph to the participant explaining the abnormal areas of concern | Other | Habit cessation counselling, management for OPMD and intraoral photographs |
Primary outcome
Habit quit rates
Time frame: 6 months
Discontinuation of habit more than 1 month.
4 secondary outcomes
Size of oral lesions
Time frame: 6 months
Oral burning sensation
Time frame: 6 months
Colour of oral lesions
Time frame: 6 months
Inter incisal mouth opening
Time frame: 6 months
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 11 Feb 2022.
- Individual participant dataSharing planned: Yes. The study data can be made available on request via email to principal investigator
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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.
Shalini Gupta, MDS,FDSRCS principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco and areca nut cessation counselling with standard management for Oral Potentially Malignant Disorders and visual exposure to personal intraoral photographs of oral lesions at baseline and review in people with Precancerous Conditions, run by All India Institute of Medical Sciences 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 2 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 11 Feb 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?
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?
Habit quit rates (time frame: 6 months). 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 11 Feb 2022.