Periodontal DiseaseNCT01489839
Biomarkers of Periodontal Disease Progression
An observational study of Periodontal Disease, run by The Forsyth Institute at 5 sites in United States.
Trial summary
The primary purpose of the study will be to look for biological biomarkers to determine which people with gum disease will have a worsening of the disease. A second objective of this study will be to look at the effects of periodontal treatment on the levels of the biomarkers that are identified. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Periodontal therapy
- How many people
- 157 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to May 2017
- Phase
- Observational
- 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
Study population: A total of 500 subjects (375 subjects with periodontal disease and 125 periodontally healthy subjects) will be enrolled at 4 centers in the US.
Who may be able to join
- General Inclusion Criteria
- To be eligible to participate in this study, a subject must meet all of the following criteria:
- Ability to understand, and willingness and ability to read and sign, the informed consent form.
- Age of at least 25 years.
- Ability to understand and follow directions for study procedures.
- Minimum of 20 natural teeth, excluding third molar teeth; at least 12 of these teeth must be pre-molars, first molars, or second molars.
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- Willingness not to have professional dental prophylaxis or scaling for the duration of the disease progression and monitoring phase (12 months).
- Willingness to comply with all study procedures and be available for the duration of the study.
- For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner).
- Specific inclusion criteria:
- Healthy periodontal subjects must have:
- Any tooth with 3 mm or less PD, irrespective of the attachment level, will be acceptable
- No teeth with PD of 4 mm or more and concomitant attachment loss, with the exception of the distal of the second molars where a PD of 4 mm and concomitant CAL of up to 2 mm will be acceptable.
- No radiographic evidence of alveolar bone loss (defined as a distance of greater than 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone); with the exception of the mandibular incisors where up to 3.0 mm of alveolar bone loss measured radiographically from the CEJ to the crest of the alveolar bone will be accepted.
- Mild periodontal disease subject: periodontal loss must meet the following criteria and must not meet the minimum criteria for severe periodontal loss:
- 1. At least 4 teeth with at least 1 site of PD of 5 mm or more and concomitant CAL greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Alveolar bone loss is defined as a distance of > 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone.
- Subjects with severe periodontal loss must meet all of the following criteria:
- 1. At least 8 separate teeth with at least 1 site of PD of 5 mm or more and concomitant CAL greater than or equal to 3 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Alveolar bone loss is defined as a distance of > 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone.
Who cannot join
- Presence of orthodontic appliances.
- The following conditions noted on oral examination:
- Oral lichen planus
- Candidiasis
- Clinical leukoplakia
- Clinical erythroplakia
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- Pemphigus
- Pemphigoid
- Other recurrent intraoral or perioral vesiculobullous diseases
- Aphthous ulcerations (major or minor). Subjects presenting with aphthous ulcers should be rescreened after 2 weeks. They will be eligible if the ulcers have healed and the subject does not have a history of frequent recurrences.
- Herpetic lesions. Subjects presenting with herpes labialis or intraoral herpes should be rescreened after 2 weeks. They will be eligible if the lesions have healed and the subject does not have a history of frequent recurrences.
- Traumatic ulcers. If a subject presents with a traumatic ulcer, he/she can be rescreened in 2-3 weeks. The subject will be eligible if the ulcers have healed.
- Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
- Root fragments, pericoronitis, endo-perio lesions, or other dental abscesses. Subjects may be rescreened after resolution of these dental conditions.
- Pregnancy or lactation.
- Requirement for prophylactic antibiotics for dental procedures (e.g., for certain heart and orthopaedic conditions*).
- Periodontal or systemic antibiotic therapy in the previous 6 months. Routine dental prophylaxis will be allowed.
- Use of cigarettes or other tobacco products within 1 year before the screening visit.
- Any medical condition that might influence the course of periodontal disease or treatment (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia).
- Chronic use of nonsteroidal anti-inflammatory drugs (e.g., for arthritis), defined as the need, or anticipated need, for over 3 weeks of continuous use at the time of enrollment or during the course of the study. The use of low-dose aspirin (81 mg/day) for prophylaxis will be allowed.
- Current or anticipated use of chronic systemic corticosteroids, cyclosporine, or other systemic immunosuppressive agent. The use of inhaled corticosteroids will be allowed.
- Hypersensitivity to tetracyclines (e.g., tetracycline, doxycycline, minocycline).
- Participation in a clinical study testing a drug, biologic, device, or other intervention within the last 30 days.
- Any condition or circumstance that, in the opinion of the investigator, would place the subject at increased risk or preclude his/her full compliance with or completion of the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
State University of New York at Buffalo
Buffalo, New York, 14228
The Forsyth Institute
Cambridge, Massachusetts, 02142
Southern Illinois University
Edwardsville, Illinois, 62026
NYU College of Dentistry
New York, New York, 10010
About this study
The primary purpose of the study will be to look for biological biomarkers to determine which people with gum disease will have a worsening of the disease. A second objective of this study will be to look at the effects of periodontal treatment on the levels of the biomarkers that are identified.
Read the detailed description
This multicenter clinical study will investigate biomarkers of periodontal disease progression. The study will enroll 375 subjects with periodontal disease and 125 periodontally healthy subjects. All subjects will be monitored clinically and have samples taken every 2 months for 12 months for analysis of inflammatory and immunological biomarkers and microbial species. Subjects displaying periodontal disease progression greater than an established threshold will receive periodontal rescue therapy at progressing periodontal sites and continue with monitoring. Periodontally healthy subjects and non-progressing sites in subjects with periodontal disease will serve as controls. After 12 months, subjects with periodontal disease will receive periodontal therapy consisting of 4 quadrants of scaling and root planing. Periodontally healthy subjects will receive prophylaxis and scaling and exit the study. Following periodontal therapy, subjects with periodontal disease will be followed for a maintenance period of 6 months for clinical and biological monitoring. Statistical analyses will compare biomarkers and microbial species between periodontally healthy subjects and subjects with periodontal disease, between progressing and non-progressing periodontally diseased sites, and between periodontally diseased sites before and after periodontal therapy.
- Conditions
- Periodontal Disease
- Being tested
- Periodontal therapy
- Keywords
- periodontal disease, biomarkers, periodontal treatment, clinical attachment level
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal therapyOther
All subjects will have professional dental prophylaxis and periodontal therapy withheld for 12 months during the disease progression and monitoring phase. After 12 months, subjects with periodontal disease will receive periodontal therapy to consist of scaling and root planing, and periodontally healthy subjects will receive professional dental prophylaxis. Subjects with periodontal disease will also receive Supportive Periodontal Therapy at the 3- and 6-month post-therapy visits. Subjects showing periodontal disease progression greater than a predetermined threshold during the monitoring or maintenance phases of the study will be given rescue therapy consisting of placement of a local antibiotic at the site of disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal diseased | Subjects with periodontal disease will be enrolled. Subjects with mild disease will have at least 4 teeth with at least 1 site with pocketing of 5 mm or more and concomitant attachment greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Subjects with severe disease will have at least 8 teeth with a site having >5mm pocketing and loss of 3 mm attachment with evidence of alveolar bone loss in 2 teeth. Receives: Other: Periodontal therapy | |
| Periodontally healthy | Periodontally healthy subjects have no teeth with pocketing of 4 mm or greater and attachment loss, with the exception of the distal of the second molars where a pocket of 4 mm and concomitant attachment of up to 2 mm will be acceptable. Healthy subjects can have up to 3 sites with gingival recession and no radiographic evidence of alveolar bone loss. Receives: Other: Periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL)
The primary study outcome will be progression of periodontal disease as determined by CAL. Initial disease progression at a site will be defined as loss of ≥2 mm in CAL at any assessment or follow-up visit compared with baseline. Subsequent disease progression will be similarly defined except that the loss in CAL will be compared with the last visit at which disease progression was detected.
Measured: After the baseline visit, subjects will return to the clinic every 2 months (± 7 days relative to baseline) for 12 months.
Secondary outcomes (1)
Biomarker Levels compared between progressing and non-progressing sites as determined by CAL changes
Biomarker levels will be compared between progressing and non-progressing periodontally diseased sites. The biomarkers include microbial species in saliva, GCF, and plaque and inflammatory and immunological markers in serum, saliva, and GCF. In addition, differences will be compared between diseased subjects before and after periodontal therapy and between periodontally diseased and healthy subjects.
Measured: Levels measured every 2 months for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), NYU Langone Health, State University of New York at Buffalo, University of Michigan, Southern Illinois University
- Responsible party
- Sponsor
- Investigators
- Ricardo P Teles, DDS, DMSc, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489839
- Sponsor's protocol ID
- 10-174-E
- Other IDs
- 5U01DE021127-02
- Status last verified
- Jun 2016
- First submitted
- 6 Dec 2011
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yost S, Duran-Pinedo AE, Teles R, Krishnan K, Frias-Lopez J. Functional signatures of oral dysbiosis during periodontitis progression revealed by microbial metatranscriptome analysis. Genome Med. 2015 Apr 27;7(1):27. doi: 10.1186/s13073-015-0153-3. eCollection 2015.
PubMed 25918553
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Periodontal Disease Progression
- ClinicalTrials.gov ID
- NCT01489839
- Acronym / sponsor ID
- 10-174-E
- Conditions
- Periodontal Disease
- Keywords
- periodontal disease, biomarkers, periodontal treatment, clinical attachment level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), NYU Langone Health, State University of New York at Buffalo, University of Michigan, Southern Illinois University
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Dec 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.
The primary purpose of the study will be to look for biological biomarkers to determine which people with gum disease will have a worsening of the disease. A second objective of this study will be to look at the effects of periodontal treatment on the levels of the biomarkers that are identified.
Detailed description
This multicenter clinical study will investigate biomarkers of periodontal disease progression. The study will enroll 375 subjects with periodontal disease and 125 periodontally healthy subjects. All subjects will be monitored clinically and have samples taken every 2 months for 12 months for analysis of inflammatory and immunological biomarkers and microbial species. Subjects displaying periodontal disease progression greater than an established threshold will receive periodontal rescue therapy at progressing periodontal sites and continue with monitoring. Periodontally healthy subjects and non-progressing sites in subjects with periodontal disease will serve as controls. After 12 months, subjects with periodontal disease will receive periodontal therapy consisting of 4 quadrants of scaling and root planing. Periodontally healthy subjects will receive prophylaxis and scaling and exit the study. Following periodontal therapy, subjects with periodontal disease will be followed for a maintenance period of 6 months for clinical and biological monitoring. Statistical analyses will compare biomarkers and microbial species between periodontally healthy subjects and subjects with periodontal disease, between progressing and non-progressing periodontally diseased sites, and between periodontally diseased sites before and after periodontal therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal diseased | – | Other: Periodontal therapySubjects with periodontal disease will be enrolled. Subjects with mild disease will have at least 4 teeth with at least 1 site with pocketing of 5 mm or more and concomitant attachment greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Subjects with severe disease will have at least 8 teeth with a site having >5mm pocketing and loss of 3 mm attachment with evidence of alveolar bone loss in 2 teeth. |
| Periodontally healthy | – | Other: Periodontal therapyPeriodontally healthy subjects have no teeth with pocketing of 4 mm or greater and attachment loss, with the exception of the distal of the second molars where a pocket of 4 mm and concomitant attachment of up to 2 mm will be acceptable. Healthy subjects can have up to 3 sites with gingival recession and no radiographic evidence of alveolar bone loss. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 500 subjects (375 subjects with periodontal disease and 125 periodontally healthy subjects) will be enrolled at 4 centers in the US.
Key inclusion criteria (18 listed)
- General Inclusion Criteria
- To be eligible to participate in this study, a subject must meet all of the following criteria:
- Ability to understand, and willingness and ability to read and sign, the informed consent form.
- Age of at least 25 years.
- Ability to understand and follow directions for study procedures.
Key exclusion criteria (24 listed)
- Presence of orthodontic appliances.
- The following conditions noted on oral examination:
- Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
- Root fragments, pericoronitis, endo-perio lesions, or other dental abscesses. Subjects may be rescreened after resolution of these dental conditions.
- Pregnancy or lactation.
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 |
|---|---|---|
| Periodontal therapyAll subjects will have professional dental prophylaxis and periodontal therapy withheld for 12 months during the disease progression and monitoring phase. After 12 months, subjects with periodontal disease will receive periodontal therapy to consist of scaling and root planing, and periodontally healthy subjects will receive professional dental prophylaxis. Subjects with periodontal disease will also receive Supportive Periodontal Therapy at the 3- and 6-month post-therapy visits. Subjects showing periodontal disease progression greater than a predetermined threshold during the monitoring or maintenance phases of the study will be given rescue therapy consisting of placement of a local antibiotic at the site of disease progression. | Other | Periodontal diseased, Periodontally healthy |
Primary outcome
Change in Clinical Attachment Level (CAL)
Time frame: After the baseline visit, subjects will return to the clinic every 2 months (± 7 days relative to baseline) for 12 months.
The primary study outcome will be progression of periodontal disease as determined by CAL. Initial disease progression at a site will be defined as loss of ≥2 mm in CAL at any assessment or follow-up visit compared with baseline. Subsequent disease progression will be similarly defined except that the loss in CAL will be compared with the last visit at which disease progression was detected.
1 secondary outcome
Biomarker Levels compared between progressing and non-progressing sites as determined by CAL changes
Time frame: Levels measured every 2 months for 12 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 7 Feb 2018.
- Derived from this study: PubMed 25918553Yost S, Duran-Pinedo AE, Teles R, Krishnan K, Frias-Lopez J. Functional signatures of oral dysbiosis during periodontitis progression revealed by microbial metatranscriptome analysis. Genome Med. 2015 Apr 27;7(1):27. doi: 10.1186/s13073-015-0153-3. eCollection 2015.
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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.
Ricardo P Teles, DDS, DMSc principal investigator
The Forsyth Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease, run by The Forsyth Institute at 5 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 18 inclusion and 24 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Change in Clinical Attachment Level (CAL) (time frame: After the baseline visit, subjects will return to the clinic every 2 months (± 7 days relative to baseline) for 12 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 NCT01489839, which also lists 1 linked publication.
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 7 Feb 2018.