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NCT01568697 · ClinicalTrials.gov registry record
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
A clinical trial of Healthy Volunteer and Healthy Subjects, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT01568697: Recruiting study of Healthy Volunteer and Healthy Subjects, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT01568697 is a study of Healthy Volunteer and Healthy Subjects that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 700 participants, above the 196-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (257% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01568697, a study of Healthy Volunteer and Healthy Subjects, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: \- To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: * Children and adults at least 7 years of age who have genetic problems with their immune system. * Healthy adults that have periodontal disease * Health adults that do not have periodontal disease Design: * This study will involve a screening visit and a study visit. * Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. * The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.
Primary Outcome
The primary clinical endpoints of the study are severity and types of oral disease: specifically for periodontal disease, mean PD, mean CAL, proportion of sites with PD \>5 mm, and proportion of subjects with BOP, proportion of patient with other inflammatory conditions or infections of the oral cavity by immune disorder.Characterization of the oral microbiome in patients with monogenic immune defects. Immunologic endpoints: types and levels of immune mediators in the saliva, GCF, oral tissues,
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2012-10-05 |
What NCT01568697 shows while recruiting
NCT01568697 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (257% higher).
The record links to 4 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 0 interventions.
NCT01568697 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01568697 about?
NCT01568697 is a clinical study titled "Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)". Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of...
What is the current status of trial NCT01568697?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2012-10-05.
What conditions does trial NCT01568697 study?
This clinical trial studies the following conditions: Healthy Volunteer, Healthy Subjects, Immunosuppression, Periodontal Disease.
Who is sponsoring clinical trial NCT01568697?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01568697 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01568697's enrollment target sits among peer trials
700 7th of 112 higher than 106 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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