PeriodontitisNCT02710903

IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis

A study testing Stent-induced biofilm overgrowth in people with Periodontitis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Periodontitis
What is being tested?: Stent-induced biofilm overgrowth
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: May 2016to 28 Mar 2018
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 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must have read, understood and signed an informed consent form in English.
Subjects must be able and willing to follow study procedures and instructions in English.
Subjects must be non-Hispanic Caucasian.
Subjects must be adult males or females with a minimum of 25 years (inclusive).
Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
Subjects must have at least 3 teeth in each posterior sextant.

Show all 12Show fewer

Subjects must be in good general health.
Subjects must present with one of the following four categories to be considered for enrollment:
Dominant IL28B and IL29 allelic with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
Dominant IL28B and IL29 allelic with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP.
IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
IL28B or IL29 SNP variants with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP

Who cannot join

Chronic disease with oral manifestations including diabetes mellitus.
Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
Gross oral pathology other than the periodontal disease.
Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).

Show all 14Show fewer

Significant organ disease including impaired renal function, heart murmur, history of rheumatic fever or valvular disease, or any bleeding disorder.
Infectious diseases such as hepatitis, HIV or tuberculosis.
Anemia or other blood dyscrasias.
Anticoagulant therapy or drugs, such as heparin or warfarin.
Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial.
Pregnant, or expect to become pregnant within the next several months.
Females of child-bearing capacity must be willing to have pregnancy test to confirm they are not pregnant.
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this 1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4 groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519; rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient procedures including oral examinations, oral prophylaxis or periodontal scaling and root planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples. Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis. Clinical outcomes will include measurements of periodontal disease progression and inflammation, such as clinical attachment level (CAL), pocket depth (PD), bleeding on probing (BOP), gingival index (GI), and plaque index (PI).

Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal disease expression and local inflammatory response during stent-induced biofilm overgrowth.

Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on cell-mediated, innate inflammatory response.

Conditions: Periodontitis
Being tested: Stent-induced biofilm overgrowth
Keywords: Periodontitis, SNP, Pathogenesis, IL29, IL28B
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stent-induced biofilm overgrowthProcedure or surgery
Customized stents will be fabricated for each subject. Stents will be fabricated to resemble an acrylic mouth-guard but extended to cover approximately 2mm over gingival margins. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will abstained from brushing and flossing teeth in one maxillary and one mandibular posterior sextant during a three- week period. Patients will be monitored for safety every week and after the induction of experimental biofilm overgrowth through 21 days

Study groups in NCT02710903
Study group	Role	What they receive
Healthy with Dominant IL28B and IL29	Experimental	Stent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with probing depths (PD) ≤4mm, no evidence of inter proximal clinical attachment loss (CAL), and <20% of sites with bleeding on probing (BOP). Receives: Procedure: Stent-induced biofilm overgrowth
Periodontal Disease with Dominant IL28B and IL29	Experimental	Stent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP. Receives: Procedure: Stent-induced biofilm overgrowth
Healthy with IL28B and/or IL29 SNP variants	Experimental	Stent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP. Receives: Procedure: Stent-induced biofilm overgrowth
Periodontal Disease with IL28B and/or IL29 SNP variants	Experimental	Stent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP. Receives: Procedure: Stent-induced biofilm overgrowth

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in pocket depth (mm)
Measured: 21 days
Change in clinical attachment level (mm)
Measured: 21 days
Change in plaque index (0-3)
Measured: 21 days
Change in bleeding on probing (Yes/No)
Measured: 21 days
Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)
Measured: 21 days
Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)
Measured: 21 days
Change in gingival crevicular fluid interleukin-29 (GCF IL-29)
Measured: 21 days
Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)
Measured: 21 days
Change in gingival index (0-4)
Measured: 21 days
Composition of the microbiota oral flora
Measured: 21 days
Change in gingival crevicular fluid interleukin-6 (GCF IL-6)
Measured: 21 days

Secondary outcomes (2)

Change in interleukin-29 expression in dendritic cells at day 35
Measured: 35 days
Change in interleukin-28B expression in dendritic cells at day 35
Measured: 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201628 Mar 2018

First posted17 Mar 2016 (estimated)
Study startMay 2016
Primary completion13 Mar 2018
Study completion28 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PeriodontitisStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02710903
Sponsor's protocol ID: 15-0637
Other IDs: 5K23DE025093-02, 5K23DE025093-03
Status last verified: Sep 2019
First submitted: 8 Dec 2015
Last updated: 26 Sep 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
ClinicalTrials.gov ID: NCT02710903
Acronym / sponsor ID: 15-0637
Conditions: Periodontitis
Keywords: Periodontitis, SNP, Pathogenesis, IL29, IL28B
Study type: Interventional
Recruitment status: Terminated
Enrolment: 79 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Study start: May 2016
Primary completion: 13 Mar 2018 (actual)
Study completion: 28 Mar 2018 (actual)
First posted: 17 Mar 2016 (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.

Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal disease expression and local inflammatory response during stent-induced biofilm overgrowth.

Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on cell-mediated, innate inflammatory response.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy with Dominant IL28B and IL29	Experimental	Procedure: Stent-induced biofilm overgrowthStent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with probing depths (PD) ≤4mm, no evidence of inter proximal clinical attachment loss (CAL), and <20% of sites with bleeding on probing (BOP).
Periodontal Disease with Dominant IL28B and IL29	Experimental	Procedure: Stent-induced biofilm overgrowthStent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP.
Healthy with IL28B and/or IL29 SNP variants	Experimental	Procedure: Stent-induced biofilm overgrowthStent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
Periodontal Disease with IL28B and/or IL29 SNP variants	Experimental	Procedure: Stent-induced biofilm overgrowthStent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP.

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subjects must have read, understood and signed an informed consent form in English.
Subjects must be able and willing to follow study procedures and instructions in English.
Subjects must be non-Hispanic Caucasian.
Subjects must be adult males or females with a minimum of 25 years (inclusive).
Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.

Key exclusion criteria (14 listed)

Chronic disease with oral manifestations including diabetes mellitus.
Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
Gross oral pathology other than the periodontal disease.
Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.

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
Stent-induced biofilm overgrowthCustomized stents will be fabricated for each subject. Stents will be fabricated to resemble an acrylic mouth-guard but extended to cover approximately 2mm over gingival margins. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will abstained from brushing and flossing teeth in one maxillary and one mandibular posterior sextant during a three- week period. Patients will be monitored for safety every week and after the induction of experimental biofilm overgrowth through 21 days	Procedure or surgery	Healthy with Dominant IL28B and IL29, Healthy with IL28B and/or IL29 SNP variants, Periodontal Disease with Dominant IL28B and IL29, Periodontal Disease with IL28B and/or IL29 SNP variants

Primary outcome

Change in pocket depth (mm)
Time frame: 21 days
Change in clinical attachment level (mm)
Time frame: 21 days
Change in plaque index (0-3)
Time frame: 21 days
Change in bleeding on probing (Yes/No)
Time frame: 21 days
Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)
Time frame: 21 days
Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)
Time frame: 21 days
Change in gingival crevicular fluid interleukin-29 (GCF IL-29)
Time frame: 21 days
Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)
Time frame: 21 days
Change in gingival index (0-4)
Time frame: 21 days
Composition of the microbiota oral flora
Time frame: 21 days
Change in gingival crevicular fluid interleukin-6 (GCF IL-6)
Time frame: 21 days

2 secondary outcomes

Change in interleukin-29 expression in dendritic cells at day 35
Time frame: 35 days
Change in interleukin-28B expression in dendritic cells at day 35
Time frame: 35 days

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.

Related trials for Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel

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.

Jim Beck, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stent-induced biofilm overgrowth in people with Periodontitis, run by University of North Carolina, Chapel Hill at 1 site 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early. Results are not available in the source record.

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?

Change in pocket depth (mm) (time frame: 21 days). The study lists 11 primary outcomes in all. 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 NCT02710903.

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 26 Sep 2019.