Aggressive PeriodontitisNCT01330719
Mechanisms and Treatment Response of Aggressive Periodontitis in Children
A study testing Diseased periodontal treatment and Conventional periodontal treatment in people with Aggressive Periodontitis, run by University of Florida at 10 sites in United States.
Trial summary
Although of low prevalence, aggressive periodontitis is a rapid destructive form of periodontal disease that initiates at a young age, leading to premature loss of first molars and incisors. Little is known on the mechanisms of this disease. Read more about this study
- Who is it for?
- Ages 5 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- Diseased periodontal treatment and Conventional periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2006to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female, aged 5 to 25
- In good general health as evidenced by medical history
- Diagnosed with localized aggressive periodontitis (LAP), defined by the presence of attachment loss ≥ 2mm and detected bone loss on at least two sites, involving first molars and/or incisors, or
- Periodontally healthy (defined by absence of clinical signs of periodontitis) related or not to LAP participants
- Male or female, up to age 90 years
- Parent or grandparent of an enrolled participant with LAP
Who cannot join
- Diagnosed with any systemic diseases or conditions that could influence the progression and/or clinical characteristics of periodontal disease (i.e., immunosuppression, diabetes, neutropenia or blood disorders).
- Patients that have taken antibiotics within the last 3 months* or require antibiotic prophylaxis prior to initial visit.
- Patients that are currently taking medications that could influence the characteristics or response to periodontal treatment (example: immune-suppressive drugs, such as cyclosporine or steroids).
- Smokers (≥10 cigarettes a day for over 6 months)
- Pregnant/lactating women as pregnancy causes gingival changes that could confound study results.
- Any psychiatric conditions that will inhibit participants from proper understanding of study procedures as determined by the PI/clinician investigator.
Show all 10Show fewer
- Patients may still enroll but will be scheduled for initial visit 3 months later
- Patients that have taken antibiotics within the last 3 months* or require antibiotic prophylaxis prior to initial visit.
- Pregnant/lactating women as pregnancy causes gingival changes that could confound study results.
- Any psychiatric conditions that will inhibit participants from proper understanding of study procedures as determined by the PI/clinician investigator.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Acorn Dental Clinic
Brooker, Florida, 32622
Broward College
Fort Lauderdale, Florida, 33301
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, 32610
Azalea Dental Clinic
Gainesville, Florida, 32640
UF Hialeah Dental Clinic
Hialeah, Florida, 33013
Duval County Department of Health
Jacksonville, Florida, 32206
University of Kentucky
Lexington, Kentucky, 40506
UF Naples Pediatric Dental Clinic
Naples, Florida, 34113
Gadsden County Health Department--Quincy Dental Clinic
Quincy, Florida, 32353
Leon County Health Department
Tallahassee, Florida, 32310
About this study
Official title: Mechanisms and Treatment Response of Aggressive Periodontitis in Children: Aberrant Immunological Phenotypes/Functions in the Progression of AgP
Although of low prevalence, aggressive periodontitis is a rapid destructive form of periodontal disease that initiates at a young age, leading to premature loss of first molars and incisors. Little is known on the mechanisms of this disease. It is imperative to understand mechanisms of disease to establish proper treatment. We have established a controlled study in a comparable population presenting similar aggressive disease characteristics to evaluate the mechanisms of this disease. It is the goal of this study to determine immunological and microbiological mechanisms responsible for the rapid tissue destruction in children with localized aggressive periodontitis and how traditional periodontal intervention affects these mechanisms. Important knowledge gained with this proposal will aid in defining specific treatment approaches to better control disease progression and prevent disease initiation in susceptible individuals.
Read the detailed description
There a multiple appointments throughout the study which can vary depending upon if a patient has the disease present or not.
If the patient has gum disease: At the initial examination, some samples will be collected: the natural fluid that comes from the gums and the bacteria that are present there will be collected by inserting a piece of paper and a filter strip in the spaces between teeth and gums; blood samples may also be taken by a phlebotomist to evaluate some inflammatory signs of disease and possible genetic markers (about 5 teaspoons at each visit); and a cheek swab may be taken by gently rubbing a little brush into the inside of the cheeks. Patients also may be asked to spit into a container we provide. Tissues from gums that are usually discarded may also be collected during treatment. When patients return for re-evaluation of their gums, all these samples may be collected again at 3, 6, 12, 18 and 24 months after the initial therapy. After 24 months, only clinical examinations may be performed, up to 3 more visits within the following 3 years.
If the patient does not have gum disease: If gums are healthy and the patient does not need treatment, they will be seen every 6 months for examination and cleanings, then sample collections may also be taken at these visits up to 24 months. These sample collections are done to be studied by genetic tests, which will tell us if there are specific genetic markers (inherited markers) associated with this disease, and also other laboratory testing, which will help the researchers identify how the body responds to bacteria. These markers will also be evaluated in family members (parents, grandparents or siblings), when possible, to check for the likelihood of these members developing this disease.
Regardless of the patient's gum condition, investigators will also evaluate current and past dental x-rays to determine if there were signs of this disease in the past.
Investigators may also take photos of the teeth and gums.
- Conditions
- Aggressive Periodontitis
- Being tested
- Diseased periodontal treatment, Conventional periodontal treatment
- Keywords
- Periodontitis
- Medical subject headings
- Aggressive Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diseased periodontal treatmentProcedure or surgery
Treatment includes scaling and root planing with systemic antibiotics, Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days. At certain intervals after the scaling and root planing, your gums will be reevaluated. You will receive further surgical gum therapy only if your gums haven't shown improvement after first treatment on the reevaluation appointments. If surgery is needed, a bone substituting material may be necessary to "fill" the spaces where bone has been destroyed by the disease. Extraction of teeth might also be part of gum treatment if the disease is very severe. Re-treatment with antibiotics also may be necessary depending on the response after treatment. You are usually re-examined and receive additional cleanings every 3 to 6 months to ensure the disease does not come back.
Conventional periodontal treatmentProcedure or surgery
Scaling and gum measurement will be taken to compare to the treated group.- If it is determined that you do not have this disease, a conventional cleaning is done, usually every 6 months. This is all part of normal clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Diseased periodontal treatment | Experimental | Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days). Receives: Procedure: Diseased periodontal treatment |
| Conventional periodontal treatment | Active comparator | Standard periodontal prophylaxis Receives: Procedure: Conventional periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNPs and DNA methylation
The investigators are doing analysis of single nucleotide polymorphisms (DNA sequence variation) and methylation (addition of a methyl group) of DNA of specific genes related to inflammation.
Measured: 24 months
Secondary outcomes (1)
Systemic inflammatory levels
The investigators are testing for systemic (plasma levels) and local (gingival fluid levels) markers of inflammation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startDec 2006
- Primary completion29 May 2019
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Ikramuddin Aukhil, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330719
- Sponsor's protocol ID
- IRB201400349-N
- Other IDs
- R01DE019456
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2011
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albandar JM. Epidemiology and risk factors of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):517-32, v-vi. doi: 10.1016/j.cden.2005.03.003.
PubMed 15978239Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.
PubMed 12102707Albandar JM. Juvenile periodontitis--pattern of progression and relationship to clinical periodontal parameters. Community Dent Oral Epidemiol. 1993 Aug;21(4):185-9. doi: 10.1111/j.1600-0528.1993.tb00753.x.
PubMed 8370252Sweeney EA, Alcoforado GA, Nyman S, Slots J. Prevalence and microbiology of localized prepubertal periodontitis. Oral Microbiol Immunol. 1987 Jun;2(2):65-70. doi: 10.1111/j.1399-302x.1987.tb00292.x.
PubMed 10870470Zambon JJ, Christersson LA, Slots J. Actinobacillus actinomycetemcomitans in human periodontal disease. Prevalence in patient groups and distribution of biotypes and serotypes within families. J Periodontol. 1983 Dec;54(12):707-11. doi: 10.1902/jop.1983.54.12.707.
PubMed 6358452Page RC, Baab DA. A new look at the etiology and pathogenesis of early-onset periodontitis. Cementopathia revisited. J Periodontol. 1985 Dec;56(12):748-51. doi: 10.1902/jop.1985.56.12.748.
PubMed 3866058Agarwal S, Suzuki JB, Riccelli AE. Role of cytokines in the modulation of neutrophil chemotaxis in localized juvenile periodontitis. J Periodontal Res. 1994 Mar;29(2):127-37. doi: 10.1111/j.1600-0765.1994.tb01101.x.
PubMed 8158501Christersson LA, Slots J, Rosling BG, Genco RJ. Microbiological and clinical effects of surgical treatment of localized juvenile periodontitis. J Clin Periodontol. 1985 Jul;12(6):465-76. doi: 10.1111/j.1600-051x.1985.tb01382.x.
PubMed 3894435Shaddox L, Wiedey J, Bimstein E, Magnuson I, Clare-Salzler M, Aukhil I, Wallet SM. Hyper-responsive phenotype in localized aggressive periodontitis. J Dent Res. 2010 Feb;89(2):143-8. doi: 10.1177/0022034509353397. Epub 2009 Dec 30.
PubMed 20042739Koutouzis T, Haber D, Shaddox L, Aukhil I, Wallet SM. Autoreactivity of serum immunoglobulin to periodontal tissue components: a pilot study. J Periodontol. 2009 Apr;80(4):625-33. doi: 10.1902/jop.2009.080422.
PubMed 19335083Alfant B, Shaddox LM, Tobler J, Magnusson I, Aukhil I, Walker C. Matrix metalloproteinase levels in children with aggressive periodontitis. J Periodontol. 2008 May;79(5):819-26. doi: 10.1902/jop.2008.070513.
PubMed 18454660Shaddox LM, Wiedey J, Calderon NL, Magnusson I, Bimstein E, Bidwell JA, Zapert EF, Aukhil I, Wallet SM. Local inflammatory markers and systemic endotoxin in aggressive periodontitis. J Dent Res. 2011 Sep;90(9):1140-4. doi: 10.1177/0022034511413928. Epub 2011 Jul 5.
PubMed 21730256Shaddox LM, Huang H, Lin T, Hou W, Harrison PL, Aukhil I, Walker CB, Klepac-Ceraj V, Paster BJ. Microbiological characterization in children with aggressive periodontitis. J Dent Res. 2012 Oct;91(10):927-33. doi: 10.1177/0022034512456039. Epub 2012 Aug 3.
PubMed 22863892Beliveau D, Magnusson I, Bidwell JA, Zapert EF, Aukhil I, Wallet SM, Shaddox LM. Benefits of early systemic antibiotics in localized aggressive periodontitis: a retrospective study. J Clin Periodontol. 2012 Nov;39(11):1075-81. doi: 10.1111/jcpe.12001. Epub 2012 Aug 29.
PubMed 22931240Goncalves PF, Huang H, McAninley S, Alfant B, Harrison P, Aukhil I, Walker C, Shaddox LM. Periodontal treatment reduces matrix metalloproteinase levels in localized aggressive periodontitis. J Periodontol. 2013 Dec;84(12):1801-8. doi: 10.1902/jop.2013.130002. Epub 2013 Mar 28.
PubMed 23537121
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Treatment Response of Aggressive Periodontitis in Children: Aberrant Immunological Phenotypes/Functions in the Progression of AgP
- ClinicalTrials.gov ID
- NCT01330719
- Acronym / sponsor ID
- IRB201400349-N
- Conditions
- Aggressive Periodontitis
- Keywords
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Dec 2006 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although of low prevalence, aggressive periodontitis is a rapid destructive form of periodontal disease that initiates at a young age, leading to premature loss of first molars and incisors. Little is known on the mechanisms of this disease. It is imperative to understand mechanisms of disease to establish proper treatment. We have established a controlled study in a comparable population presenting similar aggressive disease characteristics to evaluate the mechanisms of this disease. It is the goal of this study to determine immunological and microbiological mechanisms responsible for the rapid tissue destruction in children with localized aggressive periodontitis and how traditional periodontal intervention affects these mechanisms. Important knowledge gained with this proposal will aid in defining specific treatment approaches to better control disease progression and prevent disease initiation in susceptible individuals.
Detailed description
There a multiple appointments throughout the study which can vary depending upon if a patient has the disease present or not.
If the patient has gum disease: At the initial examination, some samples will be collected: the natural fluid that comes from the gums and the bacteria that are present there will be collected by inserting a piece of paper and a filter strip in the spaces between teeth and gums; blood samples may also be taken by a phlebotomist to evaluate some inflammatory signs of disease and possible genetic markers (about 5 teaspoons at each visit); and a cheek swab may be taken by gently rubbing a little brush into the inside of the cheeks. Patients also may be asked to spit into a container we provide. Tissues from gums that are usually discarded may also be collected during treatment. When patients return for re-evaluation of their gums, all these samples may be collected again at 3, 6, 12, 18 and 24 months after the initial therapy. After 24 months, only clinical examinations may be performed, up to 3 more visits within the following 3 years.
If the patient does not have gum disease: If gums are healthy and the patient does not need treatment, they will be seen every 6 months for examination and cleanings, then sample collections may also be taken at these visits up to 24 months. These sample collections are done to be studied by genetic tests, which will tell us if there are specific genetic markers (inherited markers) associated with this disease, and also other laboratory testing, which will help the researchers identify how the body responds to bacteria. These markers will also be evaluated in family members (parents, grandparents or siblings), when possible, to check for the likelihood of these members developing this disease.
Regardless of the patient's gum condition, investigators will also evaluate current and past dental x-rays to determine if there were signs of this disease in the past.
Investigators may also take photos of the teeth and gums.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diseased periodontal treatment | Experimental | Procedure: Diseased periodontal treatmentScaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days). |
| Conventional periodontal treatment | Active comparator | Procedure: Conventional periodontal treatmentStandard periodontal prophylaxis |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 5 to 25
- In good general health as evidenced by medical history
- Diagnosed with localized aggressive periodontitis (LAP), defined by the presence of attachment loss ≥ 2mm and detected bone loss on at least two sites, involving first molars and/or incisors, or
- Periodontally healthy (defined by absence of clinical signs of periodontitis) related or not to LAP participants
- Male or female, up to age 90 years
Key exclusion criteria (10 listed)
- Diagnosed with any systemic diseases or conditions that could influence the progression and/or clinical characteristics of periodontal disease (i.e., immunosuppression, diabetes, neutropenia or blood disorders).
- Patients that have taken antibiotics within the last 3 months* or require antibiotic prophylaxis prior to initial visit.
- Patients that are currently taking medications that could influence the characteristics or response to periodontal treatment (example: immune-suppressive drugs, such as cyclosporine or steroids).
- Smokers (≥10 cigarettes a day for over 6 months)
- Pregnant/lactating women as pregnancy causes gingival changes that could confound study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diseased periodontal treatmentTreatment includes scaling and root planing with systemic antibiotics, Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days. At certain intervals after the scaling and root planing, your gums will be reevaluated. You will receive further surgical gum therapy only if your gums haven't shown improvement after first treatment on the reevaluation appointments. If surgery is needed, a bone substituting material may be necessary to "fill" the spaces where bone has been destroyed by the disease. Extraction of teeth might also be part of gum treatment if the disease is very severe. Re-treatment with antibiotics also may be necessary depending on the response after treatment. You are usually re-examined and receive additional cleanings every 3 to 6 months to ensure the disease does not come back. | Procedure or surgery | Diseased periodontal treatment |
| Conventional periodontal treatmentScaling and gum measurement will be taken to compare to the treated group.- If it is determined that you do not have this disease, a conventional cleaning is done, usually every 6 months. This is all part of normal clinical care. | Procedure or surgery | Conventional periodontal treatment |
Primary outcome
SNPs and DNA methylation
Time frame: 24 months
The investigators are doing analysis of single nucleotide polymorphisms (DNA sequence variation) and methylation (addition of a methyl group) of DNA of specific genes related to inflammation.
1 secondary outcome
Systemic inflammatory levels
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 15978239Albandar JM. Epidemiology and risk factors of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):517-32, v-vi. doi: 10.1016/j.cden.2005.03.003.
- Background: PubMed 12102707Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.
- Background: PubMed 8370252Albandar JM. Juvenile periodontitis--pattern of progression and relationship to clinical periodontal parameters. Community Dent Oral Epidemiol. 1993 Aug;21(4):185-9. doi: 10.1111/j.1600-0528.1993.tb00753.x.
- Background: PubMed 10870470Sweeney EA, Alcoforado GA, Nyman S, Slots J. Prevalence and microbiology of localized prepubertal periodontitis. Oral Microbiol Immunol. 1987 Jun;2(2):65-70. doi: 10.1111/j.1399-302x.1987.tb00292.x.
- Background: PubMed 6358452Zambon JJ, Christersson LA, Slots J. Actinobacillus actinomycetemcomitans in human periodontal disease. Prevalence in patient groups and distribution of biotypes and serotypes within families. J Periodontol. 1983 Dec;54(12):707-11. doi: 10.1902/jop.1983.54.12.707.
- Background: PubMed 3866058Page RC, Baab DA. A new look at the etiology and pathogenesis of early-onset periodontitis. Cementopathia revisited. J Periodontol. 1985 Dec;56(12):748-51. doi: 10.1902/jop.1985.56.12.748.
- Background: PubMed 8158501Agarwal S, Suzuki JB, Riccelli AE. Role of cytokines in the modulation of neutrophil chemotaxis in localized juvenile periodontitis. J Periodontal Res. 1994 Mar;29(2):127-37. doi: 10.1111/j.1600-0765.1994.tb01101.x.
- Background: PubMed 3894435Christersson LA, Slots J, Rosling BG, Genco RJ. Microbiological and clinical effects of surgical treatment of localized juvenile periodontitis. J Clin Periodontol. 1985 Jul;12(6):465-76. doi: 10.1111/j.1600-051x.1985.tb01382.x.
- Results publication: PubMed 20042739Shaddox L, Wiedey J, Bimstein E, Magnuson I, Clare-Salzler M, Aukhil I, Wallet SM. Hyper-responsive phenotype in localized aggressive periodontitis. J Dent Res. 2010 Feb;89(2):143-8. doi: 10.1177/0022034509353397. Epub 2009 Dec 30.
- Results publication: PubMed 19335083Koutouzis T, Haber D, Shaddox L, Aukhil I, Wallet SM. Autoreactivity of serum immunoglobulin to periodontal tissue components: a pilot study. J Periodontol. 2009 Apr;80(4):625-33. doi: 10.1902/jop.2009.080422.
- Results publication: PubMed 18454660Alfant B, Shaddox LM, Tobler J, Magnusson I, Aukhil I, Walker C. Matrix metalloproteinase levels in children with aggressive periodontitis. J Periodontol. 2008 May;79(5):819-26. doi: 10.1902/jop.2008.070513.
- Results publication: PubMed 21730256Shaddox LM, Wiedey J, Calderon NL, Magnusson I, Bimstein E, Bidwell JA, Zapert EF, Aukhil I, Wallet SM. Local inflammatory markers and systemic endotoxin in aggressive periodontitis. J Dent Res. 2011 Sep;90(9):1140-4. doi: 10.1177/0022034511413928. Epub 2011 Jul 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ikramuddin Aukhil principal investigator
University of Florida
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diseased periodontal treatment and Conventional periodontal treatment in people with Aggressive Periodontitis, run by University of Florida at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNPs and DNA methylation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330719, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.