Clinical trial NCT02767050: Incidence of Caries in Smoking and Smokeless Tobacco
Official title: Incidence of Caries in Smoking and Smokeless Tobacco-An Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DENTAL CARIES
Keywords: DENTAL CARIES
TOBACCO USERS
SMOKERS
SMOKELESS TOBACCO CHEWERS
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 613
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 5-6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Institute of Dental Sciences
state: Telangana
Study officials:
affiliation: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
name: NALLAN CHAITANYA, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vellappally 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.
citation: 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.