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Withdrawn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
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
- 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
NCT ID
NCT01224002
First Posted
October 16, 2010
Last Updated
November 20, 2012
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
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Withdrawn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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