DENTAL CARIESICSSLTNCT02767050
Incidence of Caries in Smoking and Smokeless Tobacco
An observational study of DENTAL CARIES, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
The following observational study evaluates incidence of caries in smoking and smokeless tobacco based on habit history by clinical examination and DMFT index. Read more about this study
- Who is it for?
- Ages 15 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- DENTAL CARIES
- How many people
- 613 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Feb 2016
- 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 15 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients attending Panineeya Institute of Dental Sciences and Research Centre having tobacco chewing and smoking habits without fluorosis would be included in the study after their informed consent. DMFT index is scored for 613 patient of both the genders, visiting OPD of oral medicine and radiology after the clinical diagnosis of caries along with radiographs. The clinical scores are recorded along with investigations and a proforma would include the habit with duration, frequency, area of placement and form of tobacco intake.
Who may be able to join
- Patients who are willing for the study.
- A positive history of dental caries in smokers and smokeless tobacco.
- Patients with caries not under any treatment of the same.
Who cannot join
- Unwilling patients who do not want to be a part of the study.
- Patient with fluorosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Caries in Smoking and Smokeless Tobacco-An Observation Study
The following observational study evaluates incidence of caries in smoking and smokeless tobacco based on habit history by clinical examination and DMFT index.
Read the detailed description
Dental caries is an irreversible microbial disease of the calcified tissues of the teeth, characterized by demineralization of the inorganic portion and destruction of the organic substance of the tooth, which often leads to cavitation. It is a complex and dynamic process where a multitude of factors influence and initiate the progression of disease. There are practically no geographic areas in the world whose inhabitants do not exhibit some evidence of dental caries. It affects persons of both genders in all races, all socioeconomic strata and every age group. Likewise, there is strong evidence that tobacco use has numerous negative effects on oral health, for example staining of teeth, dental restoration, development of oral diseases. A biologically reasonable explanation for an association between chewing tobacco use and dental caries may be the presence of higher levels of fermentable sugars in chewing tobacco products which can stimulate the growth of carcinogenic bacteria. The decreased buffering effect possible lower pH of smokers saliva and higher number of lactobacilli and streptococcus mutans group may indicate an increased susceptibility to caries in smokers. On the other hand, there are researches which conclude that presence of extrinsic tobacco stains appear to provide a protective effect from caries.
- Conditions
- DENTAL CARIES
- Keywords
- DENTAL CARIES, TOBACCO USERS, SMOKERS, SMOKELESS TOBACCO CHEWERS
- Medical subject headings
- Dental Caries, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1: CONTROL GROUPS | Patients with no habit history of tobacco are included in group 1. | |
| GROUP 2: SMOKING TOBACCO | Patients with a history of tobacco consumption in the form of smoking. | |
| GROUP 3: SMOKELESS TOBACCO | Patients with a history of tobacco consumption in the form of chewing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries in smoking and smokeless tobacco chewers is determined by proper clinical examination of caries and is scored by DMFT index in both smoking and smokeless tobacco chewers separately and measured.
Measured: 5-6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DENTAL CARIESStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Alekhya, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- NALLAN CHAITANYA, MDS, Principal investigator, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767050
- Sponsor's protocol ID
- PMVIDS&RC/IEC/OMR/PR/0046-15
- Acronym
- ICSSLT
- Status last verified
- May 2016
- First submitted
- 15 Feb 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vellappally S, Jacob V, Smejkalova J, Shriharsha P, Kumar V, Fiala Z. Tobacco habits and oral health status in selected Indian population. Cent Eur J Public Health. 2008 Jun;16(2):77-84. doi: 10.21101/cejph.a3448.
PubMed 18661810Vellappally S, Fiala Z, Smejkalova J, Jacob V, Shriharsha P. Influence of tobacco use in dental caries development. Cent Eur J Public Health. 2007 Sep;15(3):116-21. doi: 10.21101/cejph.a3431.
PubMed 17958204Rooban T, Vidya K, Joshua E, Rao A, Ranganathan S, Rao UK, Ranganathan K. Tooth decay in alcohol and tobacco abusers. J Oral Maxillofac Pathol. 2011 Jan;15(1):14-21. doi: 10.4103/0973-029X.80032.
PubMed 21731272
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Caries in Smoking and Smokeless Tobacco-An Observation Study
- ClinicalTrials.gov ID
- NCT02767050
- Acronym / sponsor ID
- ICSSLT / PMVIDS&RC/IEC/OMR/PR/0046-15
- Conditions
- DENTAL CARIES
- Keywords
- DENTAL CARIES, TOBACCO USERS, SMOKERS, SMOKELESS TOBACCO CHEWERS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 following observational study evaluates incidence of caries in smoking and smokeless tobacco based on habit history by clinical examination and DMFT index.
Detailed description
Dental caries is an irreversible microbial disease of the calcified tissues of the teeth, characterized by demineralization of the inorganic portion and destruction of the organic substance of the tooth, which often leads to cavitation. It is a complex and dynamic process where a multitude of factors influence and initiate the progression of disease. There are practically no geographic areas in the world whose inhabitants do not exhibit some evidence of dental caries. It affects persons of both genders in all races, all socioeconomic strata and every age group. Likewise, there is strong evidence that tobacco use has numerous negative effects on oral health, for example staining of teeth, dental restoration, development of oral diseases. A biologically reasonable explanation for an association between chewing tobacco use and dental caries may be the presence of higher levels of fermentable sugars in chewing tobacco products which can stimulate the growth of carcinogenic bacteria. The decreased buffering effect possible lower pH of smokers saliva and higher number of lactobacilli and streptococcus mutans group may indicate an increased susceptibility to caries in smokers. On the other hand, there are researches which conclude that presence of extrinsic tobacco stains appear to provide a protective effect from caries.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: CONTROL GROUPS | – | –Patients with no habit history of tobacco are included in group 1. |
| GROUP 2: SMOKING TOBACCO | – | –Patients with a history of tobacco consumption in the form of smoking. |
| GROUP 3: SMOKELESS TOBACCO | – | –Patients with a history of tobacco consumption in the form of chewing. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending Panineeya Institute of Dental Sciences and Research Centre having tobacco chewing and smoking habits without fluorosis would be included in the study after their informed consent. DMFT index is scored for 613 patient of both the genders, visiting OPD of oral medicine and radiology after the clinical diagnosis of caries along with radiographs. The clinical scores are recorded along with investigations and a proforma would include the habit with duration, frequency, area of placement and form of tobacco intake.
Key inclusion criteria (3 listed)
- Patients who are willing for the study.
- A positive history of dental caries in smokers and smokeless tobacco.
- Patients with caries not under any treatment of the same.
Key exclusion criteria (2 listed)
- Unwilling patients who do not want to be a part of the study.
- Patient with fluorosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dental caries in smoking and smokeless tobacco chewers is determined by proper clinical examination of caries and is scored by DMFT index in both smoking and smokeless tobacco chewers separately and measured.
Time frame: 5-6 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 May 2016.
- Results publication: PubMed 18661810Vellappally S, Jacob V, Smejkalova J, Shriharsha P, Kumar V, Fiala Z. Tobacco habits and oral health status in selected Indian population. Cent Eur J Public Health. 2008 Jun;16(2):77-84. doi: 10.21101/cejph.a3448.
- Results publication: PubMed 17958204Vellappally S, Fiala Z, Smejkalova J, Jacob V, Shriharsha P. Influence of tobacco use in dental caries development. Cent Eur J Public Health. 2007 Sep;15(3):116-21. doi: 10.21101/cejph.a3431.
- Results publication: PubMed 21731272Rooban T, Vidya K, Joshua E, Rao A, Ranganathan S, Rao UK, Ranganathan K. Tooth decay in alcohol and tobacco abusers. J Oral Maxillofac Pathol. 2011 Jan;15(1):14-21. doi: 10.4103/0973-029X.80032.
- Individual participant dataSharing planned: No
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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.
NALLAN CHAITANYA, MDS principal investigator
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
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 DENTAL CARIES, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre 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 3 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: finished, as of the sponsor's last update on 11 May 2016. 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?
Dental caries in smoking and smokeless tobacco chewers is determined by proper clinical examination of caries and is scored by DMFT index in both smoking and smokeless tobacco chewers separately and measured. (time frame: 5-6 MONTHS). 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 NCT02767050, which also lists 3 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 11 May 2016.