Antibiotic Study for Dental Implants

A Phase 3 study testing Minocycline HCl in people with Periodontitis, run by OraPharma at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Periodontitis
What is being tested?: Minocycline HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 4 sitesUnited States
Study dates: Apr 2008to Apr 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 years of age and good general health
appropriately documented Informed Consent
willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
female subjects must meet the pregnancy and contraceptive requirements
must have oral health appropriate for study inclusion

Who cannot join

oral health inappropriate for study inclusion
females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
reporting any of the following conditions:
allergy to a tetracycline-class drug
systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis

Show all 10Show fewer

diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Trial locations and contacts

4 sites in 1 country.

United States4 sites

JJCPPW Investigational Site
Ann Arbor, Michigan, 48106
JJCPPW Investigational Site
Aurora, Colorado, 80012
JJCPPW Investigational Site
Hazlet, New Jersey, 07730
JJCPPW Investigational Site
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Read the detailed description

At Visit 1, the dentist will:

do an oral exam
ask some questions
decide if the person qualifies for being in the study
make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

do a special cleaning of the implants
examine the whole mouth
collect some fluid
take x-rays
put the people into one of two groups (taking into account whether or not they smoke)

one group will have the study antibiotic put on all the areas in their mouth with gum problems
the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

collect fluid samples
examine the whole mouth
apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

collect fluid samples
examine the whole mouth
take x-rays

Conditions: Periodontitis
Being tested: Minocycline HCl
Keywords: Peri-implantitis; antibiotic
Medical subject headings: Periodontitis, Peri-Implantitis

What participants receive

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

Minocycline HClDrug
Also called antibiotic
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Study groups in NCT00662532
Study group	Role	What they receive
Minocycline HCl	Experimental	1 mg microspheres of minocycline hydrochloride Receives: Drug: Minocycline HCl
No Intervention	No intervention	Control group receiving no drug intervention

What is being measured

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

Overall PD Reduction
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
Measured: Baseline to Day 180

Secondary outcomes (2)

Initial PD Reduction
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
Measured: Baseline to Day 90
BOP Percent Reduction From Baseline
Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline
Measured: at Day 90 and Day 180

Timeline

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

Apr 2008Apr 2009

First posted21 Apr 2008 (estimated)
Study startApr 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00662532
Sponsor's protocol ID: OP-P-5265-1
Status last verified: Dec 2011
First submitted: 17 Apr 2008
Last updated: 12 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
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
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment

All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
ClinicalTrials.gov ID: NCT00662532
Acronym / sponsor ID: OP-P-5265-1
Conditions: Periodontitis
Keywords: Peri-implantitis; antibiotic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: OraPharmaIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 21 Apr 2008 (estimated)
Results: Posted 27 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Detailed description

At Visit 1, the dentist will:

do an oral exam
ask some questions
decide if the person qualifies for being in the study
make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

do a special cleaning of the implants
examine the whole mouth
collect some fluid
take x-rays
put the people into one of two groups (taking into account whether or not they smoke)

one group will have the study antibiotic put on all the areas in their mouth with gum problems
the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

collect fluid samples
examine the whole mouth
apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

collect fluid samples
examine the whole mouth
take x-rays

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Minocycline HCl	Experimental	Drug: Minocycline HCl1 mg microspheres of minocycline hydrochloride
No Intervention	No intervention	–Control group receiving no drug intervention

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

21 years of age and good general health
appropriately documented Informed Consent
willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
female subjects must meet the pregnancy and contraceptive requirements
must have oral health appropriate for study inclusion

Key exclusion criteria (10 listed)

oral health inappropriate for study inclusion
females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
reporting any of the following conditions:
allergy to a tetracycline-class drug
systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures

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 HClAlso: antibiotic1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial	Drug	Minocycline HCl

Primary outcome

Overall PD Reduction
Time frame: Baseline to Day 180
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject

2 secondary outcomes

Initial PD Reduction
Time frame: Baseline to Day 90
BOP Percent Reduction From Baseline
Time frame: at Day 90 and Day 180

Results and safety

Results posted to the registry on 27 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Minocycline HCl	22	22
No Intervention	22	20

Primary outcome: Overall PD Reduction

Time frame: Baseline to Day 180. Mean (Standard Deviation). Unit: mm

Measure	Minocycline HCl n = 22	No Intervention n = 22
Value	1.25 (0.63)	0.66 (0.63)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 Days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Minocycline HCl	1 of 22 (4.5%)	6 of 22 (27.3%)	Not reported
No Intervention	3 of 22 (13.6%)	4 of 22 (18.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Periodontitis

Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment

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.

Michael Lynch, DMD, PhD study director

OraPharma

4 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 in people with Periodontitis, run by OraPharma at 4 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 5 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 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 27 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall PD Reduction (time frame: Baseline to Day 180). 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 NCT00662532.

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 Dec 2011.