PeriodontitisPhase 3NCT00371332
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
A Phase 3 study testing Minocycline HCL Microspheres in people with Periodontitis, run by OraPharma at 5 sites in United States.
Trial summary
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Minocycline HCL Microspheres
- How many people
- 128 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2004to not given
- Phase
- Phase 3
- 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 30 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants
Who cannot join
- Allergy to tetracycline
- Subjects with aggressive periodontitis
- Acute necrotizing ulcerative gingivitis, or gross decay
- Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
- Individuals requiring prophylactic antibiotics
- Any periodontal therapy within the previous 3 months (excluding maintenance therapy)
- Systemic or local antibiotic therapy within three months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Los Angeles, California
Study site
Memphis, Tennessee
About this study
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
- Conditions
- Periodontitis
- Being tested
- Minocycline HCL Microspheres
- Keywords
- chronic periodontitis, mouth, Moderate to advanced chronic periodontitis
- Medical subject headings
- Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline HCL MicrospheresDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary outcomes (1)
Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startJan 2004
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 128 participants
Sponsor and investigators
- Lead sponsor
- OraPharma
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371332
- Sponsor's protocol ID
- OPI-145'
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2006
- Last updated
- 25 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
- ClinicalTrials.gov ID
- NCT00371332
- Acronym / sponsor ID
- OPI-145'
- Conditions
- Periodontitis
- Keywords
- chronic periodontitis, mouth, Moderate to advanced chronic periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants
- Lead sponsor
- OraPharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- First posted
- 4 Sep 2006 (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 purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants
Key exclusion criteria (7 listed)
- Allergy to tetracycline
- Subjects with aggressive periodontitis
- Acute necrotizing ulcerative gingivitis, or gross decay
- Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
- Individuals requiring prophylactic antibiotics
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 |
|---|---|---|
| Minocycline HCL Microspheres | Drug | – |
Primary outcome
The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
1 secondary outcome
Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
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 25 Sep 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline HCL Microspheres in people with Periodontitis, run by OraPharma 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 1 inclusion and 7 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 25 Sep 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2006.