NCT00662532

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 27, 2010

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

April 17, 2008

Results QC Date

April 27, 2010

Last Update Submit

December 6, 2011

Conditions

Periodontitis

Keywords

Peri-implantitis; antibiotic

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to Day 180

Secondary Outcomes (2)

  • Initial PD Reduction

    Baseline to Day 90

  • BOP Percent Reduction From Baseline

    at Day 90 and Day 180

Study Arms (2)

Minocycline HCl

EXPERIMENTAL

1 mg microspheres of minocycline hydrochloride

Drug: Minocycline HCl

No Intervention

NO INTERVENTION

Control group receiving no drug intervention

Interventions

Minocycline HClDRUG

1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Also known as: antibiotic
Minocycline HCl

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

JJCPPW Investigational Site

Aurora, Colorado, 80012, United States

Location

JJCPPW Investigational Site

Ann Arbor, Michigan, 48106, United States

Location

JJCPPW Investigational Site

Hazlet, New Jersey, 07730, United States

Location

JJCPPW Investigational Site

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

PeriodontitisPeri-Implantitis

Interventions

MinocyclineAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance
Organization
OraPharma
bpatel@orapharma.com
215-420-4064

Study Officials

  • Michael Lynch, DMD, PhD

    OraPharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 12, 2011

Results First Posted

May 27, 2010

Record last verified: 2011-12

Locations

US(4)