Incidence of Caries in Smoking and Smokeless Tobacco (ICSSLT)

May 10, 2016 updated by: Dr.Alekhya, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

613

Contacts and Locations

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

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500060
        • Panineeya Institute of Dental Sciences

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

15 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

INCLUSION CRITERIA:

  • 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.

EXCLUSION CRITERIA:

  • Unwilling patients who do not want to be a part of the study.
  • Patient with fluorosis.

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5-6 MONTHS

Collaborators and Investigators

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

Sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Investigators

  • Principal Investigator: NALLAN CHAITANYA, MDS, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

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

December 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMVIDS&RC/IEC/OMR/PR/0046-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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