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NCT01568697
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
trial in Immunosuppression in 700 participants. Currently enrolling.
Quick facts
| Lead sponsor | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 700 |
| Start date | 5 October 2012 |
| Sites | 1 location across United States |
Conditions studied
- Immunosuppression — all drugs for Immunosuppression →
- Periodontal Disease — all drugs for Periodontal Disease →
- Healthy Subjects — all drugs for Healthy Subjects →
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Who can join
Adults 7 to 100, any sex, with Immunosuppression or Periodontal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Aggregatibacter actinomycetemcomitans-induced hypercitrullination links periodontal infection to autoimmunity in rheumatoid arthritis.
Konig MF, Abusleme L, Reinholdt J, Palmer RJ, et al · · 2016 · cited 438× · PMID 27974664 · DOI 10.1126/scitranslmed.aaj1921 -
Human oral mucosa cell atlas reveals a stromal-neutrophil axis regulating tissue immunity.
Williams DW, Greenwell-Wild T, Brenchley L, Dutzan N, et al · · 2021 · cited 376× · PMID 34129837 · DOI 10.1016/j.cell.2021.05.013 -
A dysbiotic microbiome triggers T<sub>H</sub>17 cells to mediate oral mucosal immunopathology in mice and humans.
Dutzan N, Kajikawa T, Abusleme L, Greenwell-Wild T, et al · · 2018 · cited 299× · PMID 30333238 · DOI 10.1126/scitranslmed.aat0797 -
Characterization of the human immune cell network at the gingival barrier.
Dutzan N, Konkel JE, Greenwell-Wild T, Moutsopoulos NM. · · 2016 · cited 221× · PMID 26732676 · DOI 10.1038/mi.2015.136 -
On-going Mechanical Damage from Mastication Drives Homeostatic Th17 Cell Responses at the Oral Barrier.
Dutzan N, Abusleme L, Bridgeman H, Greenwell-Wild T, et al · · 2017 · cited 198× · PMID 28087239 · DOI 10.1016/j.immuni.2016.12.010 -
Aberrant type 1 immunity drives susceptibility to mucosal fungal infections.
Break TJ, Oikonomou V, Dutzan N, Desai JV, et al · · 2021 · cited 132× · PMID 33446526 · DOI 10.1126/science.aay5731 -
Neutrophil extracellular traps and extracellular histones potentiate IL-17 inflammation in periodontitis.
Kim TS, Silva LM, Theofilou VI, Greenwell-Wild T, et al · · 2023 · cited 100× · PMID 37261457 · DOI 10.1084/jem.20221751 -
Neutrophils and neutrophil extracellular traps in oral health and disease.
Kim TS, Moutsopoulos NM. · · 2024 · cited 30× · PMID 38689085 · DOI 10.1038/s12276-024-01219-w
Verify or expand the search:
- PubMed search for NCT01568697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01568697 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Dental and Craniofacial Research (NIDCR)
- Last refreshed: 1 April 2026
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