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

Primary Purpose

Substance-Related Disorders, Dental Caries

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Substance-Related Disorders focused on measuring Cross-Sectional, Observational, Comparative, Retrospective, Feasibility, Dental Decay, Drug Abuse, Survey

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2010
    Last Updated
    November 20, 2012
    Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01224002
    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
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2012 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance-Related Disorders, Dental Caries
    Keywords
    Cross-Sectional, Observational, Comparative, Retrospective, Feasibility, Dental Decay, Drug Abuse, Survey

    7. Study Design

    Enrollment
    0 (Actual)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J. Silvio Gutkind, Ph.D.
    Organizational Affiliation
    National Institute of Dental and Craniofacial Research (NIDCR)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12271905
    Citation
    Shaner JW. Caries associated with methamphetamine abuse. J Mich Dent Assoc. 2002 Sep;84(9):42-7.
    Results Reference
    background
    PubMed Identifier
    16324229
    Citation
    Klasser GD, Epstein J. Methamphetamine and its impact on dental care. J Can Dent Assoc. 2005 Nov;71(10):759-62.
    Results Reference
    background
    PubMed Identifier
    17057044
    Citation
    Donaldson M, Goodchild JH. Oral health of the methamphetamine abuser. Am J Health Syst Pharm. 2006 Nov 1;63(21):2078-82. doi: 10.2146/ajhp060198. Erratum In: Am J Health Syst Pharm. 2006 Nov 15;63(22):2180.
    Results Reference
    background

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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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