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NCT02767050 Clinical Trial

Incidence of Caries in Smoking and Smokeless Tobacco

DENTAL CARIES Clinical Trial

— ICSSLT  

Official title:
Incidence of Caries in Smoking and Smokeless Tobacco-An Observation Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02767050
Other study ID # PMVIDS&RC/IEC/OMR/PR/0046-15
Secondary ID
Status Completed
Phase N/A
First received February 15, 2016
Last updated May 10, 2016
Start date December 2015
Est. completion date February 2016

Study information
Verified date May 2016
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 613
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 100 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
India Panineeya Institute of Dental Sciences Hyderabad Telangana

Sponsors (1)
Lead Sponsor Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (3)

Rooban 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. — View Citation

Vellappally S, Fiala Z, Smejkalová J, Jacob V, Shriharsha P. Influence of tobacco use in dental caries development. Cent Eur J Public Health. 2007 Sep;15(3):116-21. — View Citation

Vellappally S, Jacob V, Smejkalová 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 5-6 MONTHS No
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