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A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine

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ClinicalTrials.gov Identifier: NCT01224002
Recruitment Status : Withdrawn
First Posted : October 19, 2010
Last Update Posted : November 21, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date October 16, 2010
First Posted Date October 19, 2010
Last Update Posted Date November 21, 2012
Study Start Date September 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01224002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
Official Title A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
Brief Summary

The prevalence and severity of dental caries in incarcerated people who abuse drugs are unknown but an inmate reporting to the dental clinic typically presents with myriad findings: oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior teeth and interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding and clenching, and gingival inflammation. The primary risk factors for the development of caries appear to be the combination of xerostomia, frequent consumption of carbonated soft drinks, high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of these findings are seen in the other disease states, specifically in substance abuse cases, the diagnosis is often not clear. The objective of the project is to design a cross sectional comparative feasibility study that will estimate the prevalence, pattern, and severity of untreated dental decay for three types of inmates: methamphetamine abusers, substance abusers not identified as methamphetamine users, and non-substance abusers, focusing in on methamphetamine abusers as the highest risk group.

Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter explaining the study purpose and its relevance to oral health in a correctional setting will be mailed to the inmate population at two Federal Bureau of Prisons' institutions who entered the prison system during the first half of 2009. Dublin, a female FCI located in Northern California and Butner, a male FCC located in North Carolina were the selected facilities due to the high incidence of drug abusers among their inmates. The letter, which will invite all inmates to participate in the study, will inform the inmate should they consent to participate in the study that they will have their existing dental record confirmed, Central File reviewed for DSM-IV diagnosis pertinent to the study, and that they will be given a study questionnaire. Positive responses to the invitation letters will be returned to Dr. Johnson at head quarters in Washington DC. The psychology division will code the volunteer inmates into the three study groups.

Phase II. The first 30 chronologically documented volunteers in each study group category will be scheduled an appointment. A consent form will be read and explained to each inmate, in either English or Spanish as appropriate and his/her signature obtained as his/her informed consent.

Each question on the study questionnaire will be read to the inmate volunteer and the Research Associate will record the answer. A retrospective comparative study will then be employed utilizing the inmate's initial dental intake exam (routinely administered by the Federal Bureau of Prisons' dental department). The dental chart will be abstracted for dental caries. The pattern of surface-specific dental caries (DFS index) will be described and analyzed. The focus will be on the levels of untreated and treated disease diagnosed in a 4-zone partition of the oral dentition, representing a modification of the zones identified in the Grainger's caries severity index scoring system as this partition allows focus on decay patterns of anterior tooth surfaces. The multivariate summary of disease levels within each zone will be derived and statistically compared across the three study groups using Hotelling's t2-test (the multivariate extension of the Student-t test). The results of the study will be used to do a preliminary assessment between methamphetamine drug abuse and oral health and determine whether a prospective clinical study is warranted.

Detailed Description

The prevalence and severity of dental caries in incarcerated people who abuse drugs are unknown but an inmate reporting to the dental clinic typically presents with myriad findings: oral signs of uncontrolled decay on the buccal smooth surfaces of the posterior teeth and interproximal surfaces of the anterior teeth, excessive tooth wear due to grinding and clenching, and gingival inflammation. The primary risk factors for the development of caries appear to be the combination of xerostomia, frequent consumption of carbonated soft drinks, high dental plaque levels and nonexistent or inadequate oral hygiene. Since some of these findings are seen in the other disease states, specifically in substance abuse cases, the diagnosis is often not clear. The objective of the project is to design a cross sectional comparative feasibility study that will estimate the prevalence, pattern, and severity of untreated dental decay for three types of inmates: methamphetamine abusers, substance abusers not identified as methamphetamine users, and non-substance abusers, focusing in on methamphetamine abusers as the highest risk group.

Recruitment will be accomplished using a 2-phased process. Phase I. An invitation letter explaining the study purpose and its relevance to oral health in a correctional setting will be mailed to the inmate population at two Federal Bureau of Prisons' institutions who entered the prison system during the first half of 2009. Dublin, a female FCI located in Northern California and Butner, a male FCC located in North Carolina were the selected facilities due to the high incidence of drug abusers among their inmates. The letter, which will invite all inmates to participate in the study, will inform the inmate should they consent to participate in the study that they will have their existing dental record confirmed, Central File reviewed for DSM-IV diagnosis pertinent to the study, and that they will be given a study questionnaire. Positive responses to the invitation letters will be returned to Dr. Johnson at head quarters in Washington DC. The psychology division will code the volunteer inmates into the three study groups.

Phase II. The first 30 chronologically documented volunteers in each study group category will be scheduled an appointment. A consent form will be read and explained to each inmate, in either English or Spanish as appropriate and his/her signature obtained as his/her informed consent.

Each question on the study questionnaire will be read to the inmate volunteer and the Research Associate will record the answer. A retrospective comparative study will then be employed utilizing the inmate's initial dental intake exam (routinely administered by the Federal Bureau of Prisons' dental department). The dental chart will be abstracted for dental caries. The pattern of surface-specific dental caries (DFS index) will be described and analyzed. The focus will be on the levels of untreated and treated disease diagnosed in a 4-zone partition of the oral dentition, representing a modification of the zones identified in the Grainger's caries severity index scoring system as this partition allows focus on decay patterns of anterior tooth surfaces. The multivariate summary of disease levels within each zone will be derived and statistically compared across the three study groups using Hotelling's t2-test (the multivariate extension of the Student-t test). The results of the study will be used to do a preliminary assessment between methamphetamine drug abuse and oral health and determine whether a prospective clinical study is warranted.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Substance-Related Disorders
  • Dental Caries
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 20, 2012)
0
Original Estimated Enrollment
 (submitted: October 18, 2010)
180
Study Completion Date November 2012
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:
  • Inmates who have undergone medical, dental and psychological evaluation during their intake into the Butner or Dublin facilities between January 2010 and December 2010.
  • Age between 18 and 65.
  • At least 16 existing natural teeth, root tips included. The reason for choosing this relatively high number is in order to have sufficient data for an analysis of patterns of decay.

EXCLUSION CRITERIA:

  • History of head and neck radiation therapy as documented by health history
  • History of Sjogren's syndrome or similar exocrine disorders, as documented by health history
  • Currently in active orthodontic treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT01224002
Other Study ID Numbers 999910215
10-D-N215
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators Not Provided
Investigators
Principal Investigator: J. Silvio Gutkind, Ph.D. National Institute of Dental and Craniofacial Research (NIDCR)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 2012