NCT02767050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
613

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

February 15, 2016

Last Update Submit

May 10, 2016

Conditions

Keywords

DENTAL CARIESTOBACCO USERSSMOKERSSMOKELESS TOBACCO CHEWERS

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panineeya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Dental CariesTobacco Use

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • NALLAN CHAITANYA, MDS

    Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 15, 2016

First Posted

May 10, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations